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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

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: NGM282 Dose 1
NGM282 Dose 1
Biological: NGM282
NGM282

Experimental: NGM282 Dose 2
NGM282 Dose 2
Biological: NGM282
NGM282

Experimental: NGM282 Dose 3
NGM282 Dose 3
Biological: NGM282
NGM282




Primary Outcome Measures :
  1. Absolute change in plasma ALP from Baseline to Week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24 [ Time Frame: 12 weeks and 24 weeks ]


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:

  • 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

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): NCT02135536


Locations
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United States, Arizona
NGM Clinical Study Site 103
Phoenix, Arizona, United States
United States, California
NGM Clinical Study Site 108
Coronado, California, United States
United States, Michigan
NGM Clinical Study Site 101
Detroit, Michigan, United States
United States, North Carolina
NGM Clinical Study Site 105
Durham, North Carolina, United States
United States, Texas
NGM Clinical Study Site 102
Dallas, Texas, United States
NGM Clinical Study Site 113
San Antonia, Texas, United States
Australia, New South Wales
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, Australia
Australia, Queensland
NGM Clinical Study Site 614
Brisbane, Queensland, Australia
Australia, South Australia
NGM Clinical Study Site 607
Adelaide, South Australia, Australia
NGM Clinical Study Site 608
Adelaide, South Australia, Australia
Australia, Victoria
NGM Clinical Study Site 601
Melbourne, Victoria, Australia
NGM Clinical Study Site 613
Melbourne, Victoria, Australia
New Zealand
NGM Clinical Study Site 401
Auckland, New Zealand
NGM Clinical Study Site 402
Christchurch, New Zealand
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: NCT02135536     History of Changes
Other Study ID Numbers: 14-0104
First Posted: May 12, 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