NCT02135536
Completed
Phase 2
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
NGM Biopharmaceuticals, Inc17 sites in 3 countries36 target enrollmentMay 2014
ConditionsPrimary Biliary Cirrhosis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Primary Biliary Cirrhosis
- Sponsor
- NGM Biopharmaceuticals, Inc
- Enrollment
- 36
- Locations
- 17
- Primary Endpoint
- Absolute change in plasma ALP from Baseline to Week 12
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to determine the safety, tolerability, and activity of extended treatment with NGM282 in patients with Primary Biliary Cirrhosis.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Absolute change in plasma ALP from Baseline to Week 12
Time Frame: 12 weeks
Secondary Outcomes
- Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24(12 weeks and 24 weeks)
Study Sites (17)
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