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Completed

NCT Number: NCT02026401

Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

The purpose of this study is to determine the safety, tolerability, and activity of 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

  • 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

Placebo

Biological

Primary outcomes

  1. Absolute change in plasma ALP from Baseline to Day 28

    Time frame: 28 days

Secondary outcomes

  1. Absolute change in bilirubin from Baseline to Day 28

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Collaborators

  • NGM Biopharmaceuticals Australia Pty Ltd

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 3, 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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