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Completed

NCT Number: NCT02135536

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

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

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Key information

Conditions

Primary Biliary Cirrhosis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NGM Clinical Study Site 602, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NGM282

Biological

NGM282

Primary outcomes

  1. Absolute change in plasma ALP from Baseline to Week 12

    Time frame: 12 weeks

Secondary outcomes

  1. Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24

    Time frame: 12 weeks and 24 weeks

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Collaborators

  • NGM Biopharmaceuticals Australia Pty Ltd

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 12, 2014
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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