Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02135536 |
Date of registration:
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08/05/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis
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Scientific title:
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A Phase 2, Multi-Center Study to Evaluate Three Doses of NGM282 Administered for 24 Weeks in Patients With Primary Biliary Cirrhosis (PBC) Who Have Completed Study 13-0103 |
Date of first enrolment:
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May 2014 |
Target sample size:
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36 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02135536 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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New Zealand
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United States
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Contacts
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Name:
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Stephen J Rossi, PharmD |
Address:
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Telephone:
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Email:
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Affiliation:
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NGM Biopharmaceuticals, Inc |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Completion of NGM 13-0103
- Males or females, between 18 and 75 years of age, inclusive
- PBC Diagnosis consistent with AASLD and EASL guidelines
- Stable dose of UDCA
Exclusion Criteria:
- Chronic liver disease of a non-PBC etiology
- Evidence of clinically significant hepatic decompensation
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Biliary Cirrhosis
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Intervention(s)
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Biological: NGM282
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Primary Outcome(s)
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Absolute change in plasma ALP from Baseline to Week 12
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24
[Time Frame: 12 weeks and 24 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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