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Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02026401
Recruitment Status : Completed
First Posted : January 3, 2014
Last Update Posted : March 28, 2017
Sponsor:
Collaborator:
NGM Biopharmaceuticals Australia Pty Ltd
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

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

Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Biological: NGM282 Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: NGM282 Dose 1
NGM282 Dose 1
Biological: NGM282
Experimental: NGM282 Dose 2
NGM282 Dose 2
Biological: NGM282
Placebo Comparator: Placebo
Placebo
Biological: Placebo



Primary Outcome Measures :
  1. Absolute change in plasma ALP from Baseline to Day 28 [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Absolute change in bilirubin from Baseline to Day 28 [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026401


Locations
Show Show 17 study locations
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
NGM Biopharmaceuticals Australia Pty Ltd
Investigators
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Study Director: Stephen J Rossi, PharmD NGM Biopharmaceuticals, Inc
Additional Information:
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Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02026401    
Other Study ID Numbers: 13-0103
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Cirrhosis, Biliary
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases