Clinical trial NCT02135536: Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Biliary Cirrhosis
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: NGM Biopharmaceuticals Australia Pty Ltd
First posted: 2014-05-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Absolute change in plasma ALP from Baseline to Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24
timeFrame: 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: NGM Clinical Study Site 103
state: Arizona
city: Coronado
country: United States
facility: NGM Clinical Study Site 108
state: California
city: Detroit
country: United States
facility: NGM Clinical Study Site 101
state: Michigan
city: Durham
country: United States
facility: NGM Clinical Study Site 105
state: North Carolina
city: Dallas
country: United States
facility: NGM Clinical Study Site 102
state: Texas
city: San Antonia
country: United States
facility: NGM Clinical Study Site 113
state: Texas
city: Sydney
country: Australia
facility: NGM Clinical Study Site 602
state: New South Wales
city: Sydney
country: Australia
facility: NGM Clinical Study Site 606
state: New South Wales
city: Sydney
country: Australia
facility: NGM Clinical Study Site 609
state: New South Wales
city: Sydney
country: Australia
facility: NGM Clinical Study Site 611
state: New South Wales
city: Brisbane
country: Australia
facility: NGM Clinical Study Site 614
state: Queensland
city: Adelaide
country: Australia
facility: NGM Clinical Study Site 607
state: South Australia
city: Adelaide
country: Australia
facility: NGM Clinical Study Site 608
state: South Australia
city: Melbourne
country: Australia
facility: NGM Clinical Study Site 601
state: Victoria
city: Melbourne
country: Australia
facility: NGM Clinical Study Site 613
state: Victoria
city: Auckland
country: New Zealand
facility: NGM Clinical Study Site 401
city: Christchurch
country: New Zealand
facility: NGM Clinical Study Site 402
Study officials:
affiliation: NGM Biopharmaceuticals, Inc
name: Stephen J Rossi, PharmD
role: STUDY_DIRECTOR
References: