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Phase 2b Study of NGM282 Extended Treatment 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: NCT02135536
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : March 28, 2017
Sponsor:
Collaborator:
NGM Biopharmaceuticals Australia Pty Ltd
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE May 8, 2014
First Posted Date  ICMJE May 12, 2014
Last Update Posted Date March 28, 2017
Study Start Date  ICMJE May 2014
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
Absolute change in plasma ALP from Baseline to Week 12 [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24 [ Time Frame: 12 weeks and 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Biliary Cirrhosis
Intervention  ICMJE Biological: NGM282
NGM282
Study Arms  ICMJE
  • Experimental: NGM282 Dose 1
    NGM282 Dose 1
    Intervention: Biological: NGM282
  • Experimental: NGM282 Dose 2
    NGM282 Dose 2
    Intervention: Biological: NGM282
  • Experimental: NGM282 Dose 3
    NGM282 Dose 3
    Intervention: Biological: NGM282
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2016)
36
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2014)
45
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135536
Other Study ID Numbers  ICMJE 14-0104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NGM Biopharmaceuticals, Inc
Study Sponsor  ICMJE NGM Biopharmaceuticals, Inc
Collaborators  ICMJE NGM Biopharmaceuticals Australia Pty Ltd
Investigators  ICMJE
Study Director: Stephen J Rossi, PharmD NGM Biopharmaceuticals, Inc
PRS Account NGM Biopharmaceuticals, Inc
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP