Primary Biliary Cirrhosis Clinical Trial
Official title:
A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Activity of NGM282 in Combination With Ursodeoxycholic Acid (UDCA) Administered for 28 Days in Patients With Primary Biliary Cirrhosis
Verified date | March 2017 |
Source | NGM Biopharmaceuticals, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis.
Status | Completed |
Enrollment | 45 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | NGM Clinical Study Site 607 | Adelaide | South Australia |
Australia | NGM Clinical Study Site 608 | Adelaide | South Australia |
Australia | NGM Clinical Study Site 614 | Brisbane | Queensland |
Australia | NGM Clinical Study Site 601 | Melbourne | Victoria |
Australia | NGM Clinical Study Site 604 | Melbourne | Victoria |
Australia | NGM Clinical Study Site 613 | Melbourne | Victoria |
Australia | 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 |
United States | NGM Clinical Study Site 108 | Coronado | California |
United States | NGM Clinical Study Site 102 | Dallas | Texas |
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 103 | Phoenix | Arizona |
United States | NGM Clinical Study Site 104 | Richmond | Virginia |
United States | NGM Clinical Study Site 113 | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
NGM Biopharmaceuticals, Inc | NGM Biopharmaceuticals Australia Pty Ltd |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absolute change in plasma ALP from Baseline to Day 28 | 28 days | ||
Secondary | Absolute change in bilirubin from Baseline to Day 28 | 28 days |
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