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NCT02135536 Clinical Trial

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

Primary Biliary Cirrhosis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02135536
Other study ID # 14-0104
Secondary ID
Status Completed
Phase Phase 2
First received May 8, 2014
Last updated March 27, 2017
Start date May 2014
Est. completion date February 2016

Study information
Verified date March 2017
Source NGM Biopharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• NGM282
NGM282

Locations
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 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
New Zealand NGM Clinical Study Site 401 Auckland
New Zealand NGM Clinical Study Site 402 Christchurch
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 113 San Antonia Texas

Sponsors (2)
Lead Sponsor Collaborator
NGM Biopharmaceuticals, Inc NGM Biopharmaceuticals Australia Pty Ltd

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Absolute change in plasma ALP from Baseline to Week 12 12 weeks
Secondary Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24 12 weeks and 24 weeks
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