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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02200770




Registration number
NCT02200770
Ethics application status
Date submitted
16/07/2014
Date registered
25/07/2014

Titles & IDs
Public title
N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
Scientific title
A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.
Secondary ID [1] 0 0
2014-000253-36
Secondary ID [2] 0 0
CD-IA-MEDI-551-1155
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Neurological 0 0 0 0
Other neurological disorders
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Inebilizumab
Other interventions - Placebo

Placebo comparator: Placebo/Inebilizumab - Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants will receive IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.

Experimental: Inebilizumab/Inebilizumab - AQP4-IgG sero positive and sero negative participants will IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.


Treatment: Drugs: Inebilizumab
Participants will receive IV inebilizumab 300 mg.

Other interventions: Placebo
Participants will receive IV placebo matched to inebilizumab.
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
Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP
Assessment method [1] 0 0
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide. Only attacks positively adjudicated by the AC were used for the primary analysis.
Timepoint [1] 0 0
Day 1 (Baseline) through Day 197
Secondary outcome [1] 0 0
Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP
Assessment method [1] 0 0
EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.
Timepoint [1] 0 0
Day 1 (Baseline) through Day 197
Secondary outcome [2] 0 0
Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP
Assessment method [2] 0 0
Low-contrast visual acuity test is used to determine the number of letters that can be read on a standardized low-contrast Landolt C Broken Rings Chart held at a distance of 3 meters. Binocular score is the number of letters read correctly on an eye chart using both eyes simultaneously. The total score ranges from 0-70. Higher score indicates better vision.
Timepoint [2] 0 0
Day 1 (Baseline) through Day 197
Secondary outcome [3] 0 0
Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP
Assessment method [3] 0 0
The number of new gadolinium-enhancing lesions and new or enlarging T2 lesions were measured by MRI of the brain, optic nerve, and spinal cord.
Timepoint [3] 0 0
From Screening (Day -28) to Day 197
Secondary outcome [4] 0 0
Number of NMOSD-related In-patient Hospitalizations During RCP
Assessment method [4] 0 0
Participants with relapsing NMOSD have recurrent attacks that can be severe and result in blindness, paralysis, and even death and consequently, such attacks frequently result in in-patient hospitalizations. In-patient hospitalization is defined as a stay in hospital that goes beyond midnight of the first day of admission.
Timepoint [4] 0 0
Day 1 (Baseline) through Day 197
Secondary outcome [5] 0 0
Annualized AC-determined NMOSD Attack Rate During Any Exposure to Inebilizumab
Assessment method [5] 0 0
Annualized attack rate is defined as total number of AC-determined attacks divided by total person years. Total person-years is calculated as the sum of the person-years for individual participant. Person-year for individual participant = (Date of last day before safety follow-up period - first inebilizumab dose date +1)/365.25. Annualized AC-determined NMOSD attack rate during any exposure to inebilizumab (in RCP and OLP) is reported.
Timepoint [5] 0 0
For participants randomized to inebilizumab: Day 1 of RCP through end of OLP (approximately 3.5 years); and for participants randomized to placebo: Day 1 of OLP through the end of OLP (approximately 3 years)
Secondary outcome [6] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP
Assessment method [6] 0 0
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the RCP.
Timepoint [6] 0 0
Day 1 (Baseline) through Day 197
Secondary outcome [7] 0 0
Number of Participants With TEAEs and TESAEs During OLP
Assessment method [7] 0 0
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP.
Timepoint [7] 0 0
Day 198 through end of OLP period (maximum of 3 years after the last participant entered, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)
Secondary outcome [8] 0 0
Number of Participants With TEAEs and TESAEs During SFP (Open-label Population)
Assessment method [8] 0 0
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. Participant who prematurely discontinued from the RCP or OLP entered in the SFP.
Timepoint [8] 0 0
Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years)
Secondary outcome [9] 0 0
Number of Participants With TEAEs and TESAEs During SFP (Non-OLP Population)
Assessment method [9] 0 0
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. The SFP started when a participant prematurely discontinues from the RCP or OLP.
Timepoint [9] 0 0
Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years)
Secondary outcome [10] 0 0
Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP
Assessment method [10] 0 0
Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during RCP is reported.
Timepoint [10] 0 0
Day 1 (Baseline) through Day 197
Secondary outcome [11] 0 0
Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP
Assessment method [11] 0 0
Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during OLP is reported.
Timepoint [11] 0 0
Day 198 through end of OLP (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)
Secondary outcome [12] 0 0
Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP)
Assessment method [12] 0 0
Time to maximum serum concentration of inebilizumab during RCP is reported.
Timepoint [12] 0 0
Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)
Secondary outcome [13] 0 0
Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP)
Assessment method [13] 0 0
Maximum observed serum concentration of inebilizumab during RCP is reported.
Timepoint [13] 0 0
Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)
Secondary outcome [14] 0 0
Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP)
Assessment method [14] 0 0
Area under the serum concentration time curve of the dosing interval (AUC0-14d) of inebilizumab during RCP is reported.
Timepoint [14] 0 0
Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)
Secondary outcome [15] 0 0
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP)
Assessment method [15] 0 0
Number of participants with positive ADA titer to inebilizumab during RCP is reported.
Timepoint [15] 0 0
Pre and post dose on Day 1; and on Days 29, 85, and 197
Secondary outcome [16] 0 0
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During OLP)
Assessment method [16] 0 0
Number of participants with positive ADA titer to inebilizumab in OLP is reported.
Timepoint [16] 0 0
Pre and post dose on Day 1; and on Days 92, 183, 274, and then every 6 months (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)

Eligibility
Key inclusion criteria
1. Men and women 18 years or older with diagnosis of NMO/NMOSD
2. Confirmation of NMO/NMOSD status:

1. AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
2. AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
3. Able and willing to give written informed consent and comply with the requirements of the study protocol.
4. EDSS <= 7.5 (8 in special circumstances)
5. Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lactating and pregnant females
2. Treatment with any investigational agent within 4 weeks of screening
3. Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
4. Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization.
5. History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization
6. Receipt of the following at any time prior to randomization:

1. Alemtuzumab
2. Total lymphoid irradiation
3. Bone marrow transplant
4. T-cell vaccination therapy
7. Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
8. Receipt of intravenous immunoglobulin (IVIG) within 1 month prior to randomization.
9. Receipt of any of the following within 3 months prior to randomization:

1. Natalizumab (Tysabri®).
2. Cyclosporin
3. Methotrexate
4. Mitoxantrone
5. Cyclophosphamide
6. Tocilizumab
7. Eculizumab
10. History of Hepatitis B and/or Hepatitis C (Hep B/C at screening)
11. Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection
12. History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to randomization
13. Any concomitant disease other than NMO/NMOSD that required treatment with oral or intravenous steroids at doses over 20 mg a day for over 21 days

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/11/2020
Sample size
Target
Accrual to date
Final
231
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
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United States of America
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Illinois
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Kansas
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United States of America
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Maryland
Country [9] 0 0
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Michigan
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United States of America
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Minnesota
Country [11] 0 0
United States of America
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Missouri
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United States of America
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North Carolina
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Ohio
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United States of America
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Texas
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United States of America
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Virginia
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Bulgaria
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Sofia
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Varna
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British Columbia
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Colombia
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Barranquilla
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Colombia
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Bogota
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Colombia
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Cali
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Czechia
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Olomouc
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Czechia
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Praha 2
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Czechia
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Teplice
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Estonia
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Tallinn
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Estonia
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Tartu
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Düsseldorf
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Germany
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Leipzig
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Germany
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Muenster
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Germany
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Rostock
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Hong Kong
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HongKong
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Hungary
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Esztergom
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Hungary
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Nyíregyháza
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Hungary
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Szeged
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Japan
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Aomori-shi
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Japan
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Bunkyo-ku
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Japan
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Kyoto-shi
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Japan
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Ota-ku
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Japan
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Sendai-shi
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Japan
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Tsukuba
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Goyang
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Jongno-gu
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Korea, Republic of
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Seoul
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Mexico
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Ciudad De Mexico
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Mexico
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Mexico City
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Mexico
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Monterrey
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Mexico
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San Luis Potosi
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Moldova, Republic of
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Chisinau
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New Zealand
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Auckland
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Peru
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Bellavista
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Peru
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Lima
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Poland
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Katowice
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Poland
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Krakow
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Lublin
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Lódz
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Poland
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Olsztyn
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Poland
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Warszawa
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Russian Federation
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Belgorod
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Russian Federation
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Kazan
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Russian Federation
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Khabarovsk
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Ufa
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Serbia
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Belgrade
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South Africa
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Cape Town
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Spain
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Madrid
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Taiwan
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Changhua City
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Taiwan
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Hualien City
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Taiwan
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Tainan City
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Thailand
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Bangkok
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Thailand
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Muang
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
State/province [83] 0 0
Samsun

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedImmune LLC
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
MedImmune, LLC MedImmune, LLC
Address 0 0
MedImmune LLC
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02200770