Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis

Completed · Phase 2

Conditions studied: Primary Biliary Cirrhosis

In brief

The purpose of this study is to determine the safety, tolerability, and activity of extended treatment with NGM282 in patients with Primary Biliary Cirrhosis.

Key facts

Study ID

NCT02135536

Run by

NGM Biopharmaceuticals, Inc

People needed

36

Starts

2014-05-01

Expected to finish

2016-02-01

Last updated by the study team

2017-03-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Chronic liver disease of a non-PBC etiology
• Evidence of clinically significant hepatic decompensation

Where it is running

• 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 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
• NGM Clinical Study Site 614 — Brisbane, Queensland, Australia
• NGM Clinical Study Site 607 — Adelaide, South Australia, Australia
• NGM Clinical Study Site 608 — Adelaide, South Australia, Australia
• NGM Clinical Study Site 601 — Melbourne, Victoria, Australia
• NGM Clinical Study Site 613 — Melbourne, Victoria, Australia
• NGM Clinical Study Site 401 — Auckland, New Zealand
• NGM Clinical Study Site 402 — Christchurch, New Zealand

Full record on ClinicalTrials.gov

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