Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis
- Conditions
- Primary Biliary Cirrhosis
- Registration Number
- NCT02135536
- Lead Sponsor
- NGM Biopharmaceuticals, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- Chronic liver disease of a non-PBC etiology
- Evidence of clinically significant hepatic decompensation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Absolute change in plasma ALP from Baseline to Week 12 12 weeks
- Secondary Outcome Measures
Name Time Method Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24 12 weeks and 24 weeks
Trial Locations
- Locations (17)
NGM Clinical Study Site 103
🇺🇸Phoenix, Arizona, United States
NGM Clinical Study Site 108
🇺🇸Coronado, California, United States
NGM Clinical Study Site 101
🇺🇸Detroit, Michigan, United States
NGM Clinical Study Site 105
🇺🇸Durham, North Carolina, United States
NGM Clinical Study Site 102
🇺🇸Dallas, Texas, United States
NGM Clinical Study Site 113
🇺🇸San Antonia, Texas, United States
NGM Clinical Study Site 602
🇦🇺Sydney, New South Wales, Australia
NGM Clinical Study Site 606
🇦🇺Sydney, New South Wales, Australia
NGM Clinical Study Site 609
🇦🇺Sydney, New South Wales, Australia
NGM Clinical Study Site 611
🇦🇺Sydney, New South Wales, Australia
Scroll for more (7 remaining)NGM Clinical Study Site 103🇺🇸Phoenix, Arizona, United States