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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06016842




Registration number
NCT06016842
Ethics application status
Date submitted
22/08/2023
Date registered
30/08/2023

Titles & IDs
Public title
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
Scientific title
A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)
Secondary ID [1] 0 0
2023-505251-43-00
Secondary ID [2] 0 0
CLIN-60190-454
Universal Trial Number (UTN)
Trial acronym
ELFIDENCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Biliary Cholangitis (PBC) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Elafibranor
Other interventions - Matched 80 mg placebo

Experimental: Elafibranor 80 mg - Participants will take 1 tablet of elafibranor 80 mg per day orally before breakfast with a glass of water at approximately the same time each morning.

Placebo comparator: Placebo - Participants will take 1 placebo tablet per day orally (matching the 80 mg elafibranor sized tablet) before breakfast with a glass of water at approximately the same time each morning.


Treatment: Drugs: Elafibranor
Duration: up to an estimated 42-month (3.5-year) double-blind treatment period during which elafibranor 80 mg tablet will be administered once daily

Other interventions: Matched 80 mg placebo
Duration: up to an estimated 42-month (3.5-year) double-blind treatment period during which matching placebo tablet will be administered once daily
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-free survival
Timepoint [1] 0 0
From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)
Secondary outcome [1] 0 0
Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs), treatment-related TEAEs, Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs)
Timepoint [1] 0 0
From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)
Secondary outcome [2] 0 0
Percentage of participants developing clinically significant changes in physical examination findings
Timepoint [2] 0 0
From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)
Secondary outcome [3] 0 0
Percentage of participants developing clinically significant changes in vital signs
Timepoint [3] 0 0
From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)
Secondary outcome [4] 0 0
Percentage of participants developing clinically significant changes in Electrocardiogram (ECG) readings.
Timepoint [4] 0 0
From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)
Secondary outcome [5] 0 0
Percentage of participants with clinically significant changes in laboratory parameters (blood chemistry, hematology, coagulation and urinalysis)
Timepoint [5] 0 0
From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)
Secondary outcome [6] 0 0
Change from baseline in Alkaline phosphatase (ALP)
Timepoint [6] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [7] 0 0
Change from baseline in Total Bilirubin (TB)
Timepoint [7] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [8] 0 0
Percentage of participants with ALP= 1.67x ULN and TB= ULN
Timepoint [8] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [9] 0 0
Percentage of participants with complete biochemical response
Timepoint [9] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [10] 0 0
Percentage of participants with normalisation of TB and ALP
Timepoint [10] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [11] 0 0
Percentage of participants with stabilisation in TB (i.e. no increase)
Timepoint [11] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [12] 0 0
Percentage of participants with a response based on albumin normalisation
Timepoint [12] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [13] 0 0
Change from baseline in liver stiffness measurement (LSM)
Timepoint [13] 0 0
At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [14] 0 0
Change from baseline in PBC risk scores based in Global PBC Study Group (GLOBE) score
Timepoint [14] 0 0
At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [15] 0 0
Change from baseline in PBC risk scores based on United Kingdom (UK)-PBC score.
Timepoint [15] 0 0
At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [16] 0 0
Percentage of participants with LSM =15 kPa
Timepoint [16] 0 0
At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [17] 0 0
Change in serum levels of Aspartate aminotransferase (AST) compared to the baseline
Timepoint [17] 0 0
At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [18] 0 0
Change in serum levels of ALT compared to the baseline
Timepoint [18] 0 0
At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [19] 0 0
Change in serum levels of Gamma-glutamyl transferase (GGT) compared to the baseline
Timepoint [19] 0 0
At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [20] 0 0
Change from baseline in hepatic function: Conjugated bilirubin
Timepoint [20] 0 0
At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [21] 0 0
Change in serum levels of Albumin compared to the baseline
Timepoint [21] 0 0
At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [22] 0 0
Change from baseline in hepatic function: international normalised ratio (INR)
Timepoint [22] 0 0
At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [23] 0 0
Change from baseline in hepatic function: fractionated ALP
Timepoint [23] 0 0
At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [24] 0 0
Percentage of participants with no worsening of LSM
Timepoint [24] 0 0
At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [25] 0 0
Percentage of participants with ALP reduction of 40%
Timepoint [25] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [26] 0 0
Percentage of participants with ALP <1.5x ULN, ALP decrease =15% and TB =ULN
Timepoint [26] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [27] 0 0
Percentage of participants with ALP <1.5x ULN, ALP decrease =40% and TB =ULN
Timepoint [27] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [28] 0 0
Percentage of participants with ALP <1.67x ULN, ALP decrease =15% and TB =ULN
Timepoint [28] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [29] 0 0
Percentage of participants with ALP <3x ULN, AST <2x ULN and TB =1 mg/dL (Paris I)
Timepoint [29] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [30] 0 0
Percentage of participants with ALP =1.5x ULN, AST =1.5x ULN and TB =1 mg/dL (Paris II criteria)
Timepoint [30] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [31] 0 0
Percentage of participants with normalisation of abnormal TB
Timepoint [31] 0 0
Assessed at Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [32] 0 0
Percentage of participants with normalisation of abnormal TB and albumin (Rotterdam criteria)
Timepoint [32] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [33] 0 0
Percentage of participants with reduction in TB to =0.6x ULN in participants with TB >0.6x ULN at baseline
Timepoint [33] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [34] 0 0
Change from baseline in lipid parameters: total cholesterol (TC)
Timepoint [34] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [35] 0 0
Change from baseline in lipid parameters: high density lipoprotein cholesterol (HDL-C)
Timepoint [35] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [36] 0 0
Change from baseline in lipid parameters: calculated very low density lipoprotein cholesterol (VLDL-C)
Timepoint [36] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [37] 0 0
Change from baseline in lipid parameters: low density lipoprotein cholesterol (LDL-C)
Timepoint [37] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [38] 0 0
Change from baseline in lipid parameters: triglycerides (TG)
Timepoint [38] 0 0
At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [39] 0 0
Percentage of participants with a response in PBC Worst Itch NRS score
Timepoint [39] 0 0
Through 6 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [40] 0 0
Percentage of participants with a response in PBC Worst Itch NRS
Timepoint [40] 0 0
Assessed through 6 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [41] 0 0
Change from baseline in 5D-Itch scale
Timepoint [41] 0 0
Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [42] 0 0
Change from baseline in Patient Global Impression of Severity (PGI-S)
Timepoint [42] 0 0
Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [43] 0 0
Patient Global Impression of Change (PGI-C)
Timepoint [43] 0 0
Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [44] 0 0
Change from baseline in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 7a
Timepoint [44] 0 0
Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [45] 0 0
Change from baseline in the Epworth Sleepiness Scale (ESS)
Timepoint [45] 0 0
Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [46] 0 0
Change from baseline in PBC-40 score
Timepoint [46] 0 0
Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [47] 0 0
Change from baseline in PBC Worst Itch Numeric Rating Scale (NRS) score
Timepoint [47] 0 0
Assessed through 6 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [48] 0 0
Change from baseline in EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L)
Timepoint [48] 0 0
Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [49] 0 0
Change from baseline in Work Productivity and Activity Impairment General Health (WPAI-GH)
Timepoint [49] 0 0
Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Secondary outcome [50] 0 0
Time to the first occurrence of each of individual adjudicated clinical outcome events
Timepoint [50] 0 0
From baseline until 4 weeks after the end of treatment
Secondary outcome [51] 0 0
Area under the plasma concentration-time curve from time 0 to 24 hours: AUC0-24
Timepoint [51] 0 0
At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
Secondary outcome [52] 0 0
Maximum (peak) plasma drug concentration: Cmax
Timepoint [52] 0 0
At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
Secondary outcome [53] 0 0
Time to reach maximum (peak) plasma concentration following drug administration): Tmax
Timepoint [53] 0 0
At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
Secondary outcome [54] 0 0
Apparent clearance of drug from plasma (CL)
Timepoint [54] 0 0
At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
Secondary outcome [55] 0 0
Apparent volume of distribution (VZ)
Timepoint [55] 0 0
At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
Secondary outcome [56] 0 0
Change from baseline in model for end-stage liver disease (MELD) 3.0 score
Timepoint [56] 0 0
From screening until end of treatment (maximum duration of 3.5 years)
Secondary outcome [57] 0 0
Change from baseline in Child Pugh grade
Timepoint [57] 0 0
From screening until end of treatment (maximum duration of 3.5 years)

Eligibility
Key inclusion criteria
Inclusion Criteria :

* Male or female participants must be =18 years of age at the time of signing the informed consent.
* Participants with a definite or probable diagnosis of primary biliary cholangitis (PBC)
* Participants with cirrhosis at SV1. • Participants must be Child Pugh A or Child Pugh B.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria :

* History or presence of other concomitant liver disease including but not limited to:

* i) Primary sclerosing cholangitis (PSC).
* ii) Autoimmune hepatitis (AIH) by simplified Diagnostic Criteria of the International Autoimmune Hepatitis Group (IAIHG) =6, or if treated for an overlap of PBC with AIH, or if there is clinical suspicion and evidence of overlap AIH features, that cannot be explained alone by insufficient response to UDCA.
* iii) Positive hepatitis B surface antigen (HBsAg). Participants with negative HBsAg and positive hepatitis B core antibody (HBcAb) may be eligible if hepatitis B virus deoxyribonucleic acid (HBV DNA) is negative.
* iv) Hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA) (Note: Participants with positive anti-HCV antibody due to previously treated HCV infection, may be enrolled if a confirmatory HCV RNA is undetectable and sustained viral response has been documented).
* v) Alcohol-associated liver disease (ALD).
* vi) Nonalcoholic steatohepatitis (NASH).
* vii) Other chronic liver diseases, such as alpha-1 antitrypsin deficiency.
* History or presence of clinically significant hepatic decompensation, including:

* i) History of liver transplantation, current placement on a liver transplant list, current model for end-stage liver disease including (MELD) 3.0 score >12 due to hepatic impairment.
* ii) Evidence of complications of cirrhosis, including hepatic decompensation or evidence of significant portal hypertension complications including presence of uncontrolled ascites; history of variceal bleeding or related interventions (e.g. variceal banding, or transjugular intrahepatic portosystemic shunt placement); presence of hepatic encephalopathy Grade 2 or higher per West-Haven criteria; history or presence of spontaneous bacterial peritonitis. Note: participants with low-risk varices (Grade I) without history of bleeding or other treatment may be eligible to enrol.
* iii) Hepatorenal syndrome (HRS) (type I or II ). • vi) Hospitalisation for liver-related complication within 12 weeks prior to SV1.
* Known history of human immunodeficiency virus (HIV) infection or having a positive confirmatory test for HIV type 1 or 2.
* Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
* Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric disease as evaluated by the investigator; other clinically significant conditions that are not well controlled.
* Non-hepatic medical conditions that may diminish life expectancy to <2 years, including known cancers.
* History of hepatocellular carcinoma.
* Alpha-fetoprotein (AFP) >20 ng/mL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) imaging suggesting presence of hepatocellular carcinoma.
* Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix.
* Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below: • i) 3 months prior to screening period: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including a-methyl-dopa, sodium valproic acid, isoniazid or nitrofurantoin).
* Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer, prior to the screening period.

i) If the previous study was for an experimental therapy being studied for potential benefit in PBC, and the potential therapeutic agent was proven to have no beneficial effect in PBC and there are no safety concerns, the participant may enrol after 30 days or 5 half-lives from the last dose of the therapeutic agent, whichever is longer.ii) For therapeutic agents being studied for potential benefit in PBC for which it is still unclear if there may be a potential benefit, participants may enrol after 6 months from the last dose of the therapeutic agent.
* Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) >450 msec in males or QTcF >470 msec in females for participants without bundle branch block. For participants with bundle branch block or other intraventricular conduction delay, a longer QTcF >480 msec would be exclusionary.
* Total bilirubin (TB) >5x ULN
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5x ULN at SV1
* Creatinine phosphokinase (CPK) >2x ULN.
* Platelet count <50,000/µL
* International normalised ratio (INR) >1.8 in the absence of anticoagulant therapy.
* Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 per the Modification of Diet in Renal Disease (MDRD)-6 Study formula at SV1.
* Significant renal disease, including nephritic syndrome, chronic kidney disease (CKD) (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury).
* For female participants: known current pregnancy, or has a positive serum pregnancy test, or is breastfeeding.
* Regular alcohol intake in excess of the recommended limit of 1 standard drink per day for men or women.
* History of alcohol abuse, or other substance abuse within 1 year prior to SV1.
* Known hypersensitivity to elafibranor or to any of the excipients of the investigational product(s).
* Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
* Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high risk of noncompliance with the study.
* Alkaline phosphatase (ALP) =10x ULN.
* Albumin <2.8 g/dL due to impaired hepatic function.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2029
Actual
Sample size
Target
276
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 0 0
Footscray Hospital, Western Health - Footscray
Recruitment hospital [3] 0 0
Nepean Clinical School - Kingswood
Recruitment hospital [4] 0 0
Monash University - Monash Health -Monash Medical Centre - Melbourne
Recruitment hospital [5] 0 0
St George Hospital - Sydney
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Birtinya
Recruitment postcode(s) [2] 0 0
- Footscray
Recruitment postcode(s) [3] 0 0
- Kingswood
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Córdoba
Country [18] 0 0
Argentina
State/province [18] 0 0
Mendoza
Country [19] 0 0
Argentina
State/province [19] 0 0
Pilar
Country [20] 0 0
Belgium
State/province [20] 0 0
Edegem
Country [21] 0 0
Belgium
State/province [21] 0 0
Genk
Country [22] 0 0
Belgium
State/province [22] 0 0
Gent
Country [23] 0 0
Belgium
State/province [23] 0 0
Roeselare
Country [24] 0 0
Brazil
State/province [24] 0 0
Porto Alegre
Country [25] 0 0
Brazil
State/province [25] 0 0
São Paulo
Country [26] 0 0
Chile
State/province [26] 0 0
Las Condes
Country [27] 0 0
Chile
State/province [27] 0 0
Santiago
Country [28] 0 0
Chile
State/province [28] 0 0
Viña Del Mar
Country [29] 0 0
Czechia
State/province [29] 0 0
Hradec Králové
Country [30] 0 0
Czechia
State/province [30] 0 0
Liberec
Country [31] 0 0
Czechia
State/province [31] 0 0
Ostrava
Country [32] 0 0
Czechia
State/province [32] 0 0
Plzen
Country [33] 0 0
Czechia
State/province [33] 0 0
Prague
Country [34] 0 0
France
State/province [34] 0 0
Lille
Country [35] 0 0
France
State/province [35] 0 0
Lyon
Country [36] 0 0
France
State/province [36] 0 0
Marseille
Country [37] 0 0
France
State/province [37] 0 0
Nice
Country [38] 0 0
France
State/province [38] 0 0
Paris
Country [39] 0 0
France
State/province [39] 0 0
Poitiers
Country [40] 0 0
France
State/province [40] 0 0
Toulouse
Country [41] 0 0
France
State/province [41] 0 0
Villejuif
Country [42] 0 0
Italy
State/province [42] 0 0
Modena
Country [43] 0 0
Italy
State/province [43] 0 0
Monza
Country [44] 0 0
Italy
State/province [44] 0 0
Naples
Country [45] 0 0
Italy
State/province [45] 0 0
Padova
Country [46] 0 0
Italy
State/province [46] 0 0
Palermo
Country [47] 0 0
Italy
State/province [47] 0 0
Pavia
Country [48] 0 0
Italy
State/province [48] 0 0
Pisa
Country [49] 0 0
Italy
State/province [49] 0 0
San Giovanni Rotondo
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Busan
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Daegu
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Daejeon
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Gyeonggi-do
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Junggu
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Seongnam-si
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seoul
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Uijeongbu
Country [58] 0 0
Mexico
State/province [58] 0 0
Ciudad de mexico
Country [59] 0 0
Mexico
State/province [59] 0 0
Jalisco
Country [60] 0 0
Mexico
State/province [60] 0 0
Yucatán
Country [61] 0 0
New Zealand
State/province [61] 0 0
Christchurch
Country [62] 0 0
New Zealand
State/province [62] 0 0
Hamilton
Country [63] 0 0
Poland
State/province [63] 0 0
Elblag
Country [64] 0 0
Poland
State/province [64] 0 0
Katowice
Country [65] 0 0
Poland
State/province [65] 0 0
Kraków
Country [66] 0 0
Poland
State/province [66] 0 0
Malogoskie
Country [67] 0 0
Poland
State/province [67] 0 0
Sosnowiec
Country [68] 0 0
Poland
State/province [68] 0 0
Warszawa
Country [69] 0 0
Poland
State/province [69] 0 0
Wroclaw
Country [70] 0 0
Romania
State/province [70] 0 0
Bucharest
Country [71] 0 0
Romania
State/province [71] 0 0
Cluj-Napoca
Country [72] 0 0
Romania
State/province [72] 0 0
Iasi
Country [73] 0 0
Spain
State/province [73] 0 0
Barcelona
Country [74] 0 0
Spain
State/province [74] 0 0
Madrid
Country [75] 0 0
Spain
State/province [75] 0 0
Majadahonda
Country [76] 0 0
Spain
State/province [76] 0 0
Málaga
Country [77] 0 0
Spain
State/province [77] 0 0
Pontevedra
Country [78] 0 0
Spain
State/province [78] 0 0
Sabadell
Country [79] 0 0
Spain
State/province [79] 0 0
Sevilla
Country [80] 0 0
Spain
State/province [80] 0 0
Valencia
Country [81] 0 0
Spain
State/province [81] 0 0
Valladolid
Country [82] 0 0
Spain
State/province [82] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ipsen Clinical Study Enquiries
Address 0 0
Country 0 0
Phone 0 0
See e mail
Fax 0 0
Email 0 0
clinical.trials@ipsen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
When will data be available (start and end dates)?
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Available to whom?
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/members/ourmembers/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06016842