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NCT02026401 Clinical Trial

Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02026401
Other study ID # 13-0103
Secondary ID
Status Completed
Phase Phase 2
First received December 30, 2013
Last updated March 27, 2017
Start date February 2014
Est. completion date December 2014

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 NGM282 in patients with Primary Biliary Cirrhosis.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• NGM282

• Placebo

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 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

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

Countries where clinical trial is conducted

United States,  Australia, 

Outcome
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
See also
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Active, not recruiting NCT04751188 - A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis Phase 3
Recruiting NCT04514965 - Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
Recruiting NCT03668145 - Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary Cholangitis N/A
Completed NCT02955602 - Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC) Phase 2
Completed NCT02557360 - Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis Phase 4
Recruiting NCT01440309 - Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis Phase 1
Completed NCT01249092 - Pentoxifylline for Primary Biliary Cirrhosis Phase 2
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