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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02403323
Registration number
NCT02403323
Ethics application status
Date submitted
26/03/2015
Date registered
31/03/2015
Date last updated
2/12/2024
Titles & IDs
Public title
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
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Scientific title
An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144
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Secondary ID [1]
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2014-003855-76
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Secondary ID [2]
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GA29145
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Universal Trial Number (UTN)
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Trial acronym
JUNIPER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn Disease
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Condition category
Condition code
Oral and Gastrointestinal
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0
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
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0
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Etrolizumab
Experimental: Part 1: Etrolizumab Open-Label Extension - Participants will receive open-label treatment with etrolizumab once every 4 weeks until commercial availability in their country or sponsor's decision to terminate the study, whichever is earlier (up to approximately 10 years after the first patient is enrolled).
No intervention: Part 2: Safety Monitoring - Participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 \[NCT02394028\]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.
Treatment: Drugs: Etrolizumab
105 mg etrolizumab subcutaneous administration once every 4 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals
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Assessment method [1]
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CDAI is a score obtained from composite of eight assessments: number of liquid or soft stools, abdominal pain, general well-being, presence of complications, taking lomotil (diphenoxylate/atropine) or other opiates for diarrhea, presence of an abdominal mass, hematocrit, and percentage deviation from standard weight. A decrease in CDAI over time indicates improvement in disease activity. CDAI scores range from 0 to 600. A higher score indicates worse outcome. A total score of less than 150 corresponds to remission.
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Timepoint [1]
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Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE
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Primary outcome [2]
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Part 1: Number of Participants With Clinical Remission at 12-week Intervals
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Assessment method [2]
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Clinical remission was defined as a liquid/soft stool frequency (SF) mean daily score =3 and an abdominal pain (AP) mean daily score =1 with no worsening in either subscore compared to baseline, where the average was taken over 7 days prior to visit. Abdominal pain severity was assessed using the abdominal pain questionnaire which is an 11-point numeric rating scale with score ranging from 0 (no pain) to 10 (worse pain). Liquid/soft stool frequency was reported using the bristol stool form scale which classifies stools into seven groups based on its consistency i.e., type 1- separate hard lumps, type 2- sausage-shaped but lumpy, type 3- like a sausage but with cracks on the surface, type 4- like a sausage or snake, smooth and soft, type 5- soft blobs with clear-cut edges, type 6- fluffy pieces with ragged edges and type 7- entirely liquid with no solid pieces.
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Timepoint [2]
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Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE
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Primary outcome [3]
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Part 1: Number of Participants With Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108
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Assessment method [3]
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SES-CD is an endoscopic score composite of 4 variables (ulcers size, percentage of ulcerated surface, inflamed surface, and presence of narrowing) in up to 5 ileocolonic segments (ileum right, colon, transverse colon, left colon, rectum) and scored on a scale of 0-3, with total score from 0-60. Higher score indicates higher ulcer surface/size in the 4 variables. Endoscopic improvement was defined as =50% reduction in SES-CD score compared to baseline.
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Timepoint [3]
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At OLE Week 108
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Primary outcome [4]
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Part 1: Number of Participants With Adverse Event (AE) and Severity of AEs as Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)
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Assessment method [4]
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An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. AEs were graded as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4=Life threatening consequences, urgent intervention indicated; Grade 5=Death related to AE. Multiple occurrences of AEs in the same category at the worst (highest) NCIC-CTCAE grade for an individual are counted only once.
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Timepoint [4]
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From Day 1 up to end of 12-week safety follow-up in OLE (approximately 6.3 years)
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Primary outcome [5]
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Part 1: Number of Participants With Serious Adverse Events (SAEs)
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Assessment method [5]
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigation, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
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Timepoint [5]
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From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
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Primary outcome [6]
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Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0
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Assessment method [6]
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AE=untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. AEs were graded per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event. If a participant experienced multiple occurrences of AEs at different grades, they were counted in each grade where they had at least one AE of that grade.
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Timepoint [6]
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From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
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Primary outcome [7]
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Part 1: Incidence Rate of Infection-related Adverse Event
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Assessment method [7]
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An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. AE rate (per 100 participant years) = \[Total number of AEs (in OLE only) / Total number of participant years at risk (in OLE only)\]\*100. Total participant-years at risk is the sum over all participants of the time intervals (in years) from the first dose of study treatment in Part 1 (OLE) until the participant completes/withdraws from the study (including the 12-week safety follow-up, if applicable).
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Timepoint [7]
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From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
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Primary outcome [8]
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Part 1: Number of Participants With Serious Infection Related AES
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Assessment method [8]
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigation, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
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Timepoint [8]
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From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
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Primary outcome [9]
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Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0
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Assessment method [9]
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AE=untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Injection-site reaction=any local reaction occurring at the site of injection following study drug administration. Signs (e.g., erythema, induration/swelling at injection site) and symptoms (e.g., pain, pruritus at injection site). Injection site reactions were graded per NCI CTCAE v4.0. Grade 1=Tenderness with or without associated symptoms (e.g., warmth, erythema, itching); Grade 2=Pain; lipodystrophy; edema; phlebitis; Grade 3=Ulceration or necrosis; severe tissue damage; operative intervention indicated; Grade 4=life-threatening consequences or urgent intervention indicated; Grade=5 death related to AE.
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Timepoint [9]
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From Day 1 up to end of safety 12-week follow-up in OLE (approximately 6.3 years)
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Primary outcome [10]
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Part 1: Number of Participants With Adverse Events Leading to Etrolizumab Discontinuation
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Assessment method [10]
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An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Number of participants who discontinued etrolizumab treatment during the OLE period have been reported here.
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Timepoint [10]
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From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
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Primary outcome [11]
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Part 1: Number of Participants With Malignancies
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Assessment method [11]
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Number of participants who developed malignancies during the OLE period have been reported here.
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Timepoint [11]
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From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
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Primary outcome [12]
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Part 1: Incidence Rate of Malignancies
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Assessment method [12]
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Malignancy rate (per 100 participant years) = \[Total number of malignancies (in OLE only) / Total number of participant years at risk (in OLE only)\]\*100. Total participant-years at risk is the sum over all participants of the time intervals (in years) from the first dose of study treatment in Part 1 (OLE) until the participant completes/withdraws from the study (including the 12-week safety follow-up, if applicable).
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Timepoint [12]
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From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
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Primary outcome [13]
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Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0
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Assessment method [13]
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Hypersensitivity was reported using the MedDRA anaphylactic reaction standard MedDRA query (SMQ) and Sampson's criteria. Hypersensitivity was assessed as per NCI CTCAE v4.0. Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2 = Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3 = Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living.
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Timepoint [13]
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From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years)
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Primary outcome [14]
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Part 2: Number of Participants With Confirmed or Suspected Progressive Multifocal Leukoencephalopathy (PML)
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Assessment method [14]
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PML was assessed by the PML Subjective Checklist (symptom assessment) and the PML Objective Checklist (neurologic evaluation).
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Timepoint [14]
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From end of safety follow-up in Part 1 or study GA29144 up to maximum of 92 weeks
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Eligibility
Key inclusion criteria
Part 1 Open-Label Extension:
* Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who meet the eligibility criteria for open-label etrolizumab as described in the protocol
Part 2 Safety Monitoring:
* Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are not eligible or choose not to enter Part 1
* Patients who transfer from Part 1
* Completion of the 12-week safety follow-up period prior to entering
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Part 1 Open-Label Extension:
* Any new, significant, uncontrolled condition
Part 2 Safety Monitoring:
* No exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/06/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/10/2023
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Sample size
Target
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Accrual to date
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Final
790
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Recruitment hospital [2]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [3]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [4]
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University of the Sunshine Coast - Sippy Downs
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Recruitment hospital [5]
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Mater Adult Hospital - South Brisbane
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Recruitment hospital [6]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [7]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [8]
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St Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [9]
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Footscray Hospital - Footscray
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Recruitment hospital [10]
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St Frances Xavier Cabrini Hospital - Malvern
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Recruitment hospital [11]
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Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics - Parkville
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Recruitment hospital [12]
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The Alfred Hospital - Prahan
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Recruitment hospital [13]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2065 - Garran
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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4556 - Sippy Downs
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Recruitment postcode(s) [5]
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4101 - South Brisbane
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Recruitment postcode(s) [6]
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4102 - Woolloongabba
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Recruitment postcode(s) [7]
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5042 - Bedford Park
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Recruitment postcode(s) [8]
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3065 - Fitzroy
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Recruitment postcode(s) [9]
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3011 - Footscray
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Recruitment postcode(s) [10]
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3144 - Malvern
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Recruitment postcode(s) [11]
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3050 - Parkville
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Recruitment postcode(s) [12]
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3181 - Prahan
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Recruitment postcode(s) [13]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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0
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United States of America
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Colorado
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0
0
United States of America
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Florida
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0
0
United States of America
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Georgia
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0
0
United States of America
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Idaho
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0
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United States of America
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0
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Illinois
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0
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Kansas
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United States of America
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State/province [8]
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Louisiana
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0
0
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Michigan
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Minnesota
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0
0
United States of America
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State/province [11]
0
0
Mississippi
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0
0
United States of America
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State/province [12]
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Missouri
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New York
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United States of America
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North Carolina
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0
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Argentina
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0
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Caba
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0
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Austria
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Salzburg
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0
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Austria
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0
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Wien
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0
0
Belgium
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0
0
Brussel
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0
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Belgium
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0
0
Bruxelles
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0
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Belgium
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0
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Edegem
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0
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Belgium
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State/province [31]
0
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Gent
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0
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Brazil
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0
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GO
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0
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Brazil
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MG
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0
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Brazil
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PR
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0
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Brazil
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RJ
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0
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Brazil
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0
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RS
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0
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Brazil
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0
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SP
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Country [38]
0
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Bulgaria
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0
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Sofia
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0
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Canada
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State/province [39]
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0
Alberta
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0
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Canada
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0
0
British Columbia
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0
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Canada
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0
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Manitoba
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0
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Canada
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0
Nova Scotia
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0
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Canada
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State/province [43]
0
0
Ontario
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0
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Canada
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0
0
Quebec
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0
0
Canada
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0
0
Saskatchewan
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0
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Croatia
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0
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Osijek
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0
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Croatia
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0
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Pula
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Country [48]
0
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Croatia
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State/province [48]
0
0
Zagreb
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0
0
Czechia
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State/province [49]
0
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Brno
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0
0
Czechia
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0
0
Ceske Budejovice
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Country [51]
0
0
Czechia
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State/province [51]
0
0
Hradec Kralove
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Country [52]
0
0
Czechia
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State/province [52]
0
0
Olomouc
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Country [53]
0
0
Czechia
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State/province [53]
0
0
Ostrava - Poruba
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Country [54]
0
0
Czechia
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State/province [54]
0
0
Praha 7
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Country [55]
0
0
Czechia
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State/province [55]
0
0
Praha
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Country [56]
0
0
Estonia
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State/province [56]
0
0
Tallinn
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Country [57]
0
0
Estonia
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State/province [57]
0
0
Tartu
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Country [58]
0
0
France
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State/province [58]
0
0
Amiens
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Country [59]
0
0
France
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Funding & Sponsors
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Commercial sector/industry
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Name
Hoffmann-La Roche
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Summary
Brief summary
This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 \[NCT02394028\]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.
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Trial website
https://clinicaltrials.gov/study/NCT02403323
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Trial related presentations / publications
Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/23/NCT02403323/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/23/NCT02403323/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02403323
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