Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis
Phase 2
Completed
- Conditions
- Primary Biliary Cirrhosis
- Registration Number
- NCT02026401
- Lead Sponsor
- NGM Biopharmaceuticals, Inc
- Brief Summary
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Absolute change in plasma ALP from Baseline to Day 28 28 days
- Secondary Outcome Measures
Name Time Method Absolute change in bilirubin from Baseline to Day 28 28 days
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 Antonio, Texas, United States
NGM Clinical Study Site 104
🇺🇸Richmond, Virginia, 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
Scroll for more (7 remaining)NGM Clinical Study Site 103🇺🇸Phoenix, Arizona, United States