Clinical trial NCT02026401: Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis
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 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: 2014-01-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Absolute change in plasma ALP from Baseline to Day 28
timeFrame: 28 days
Secondary outcomes:
measure: Absolute change in bilirubin from Baseline to Day 28
timeFrame: 28 days
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 Antonio
country: United States
facility: NGM Clinical Study Site 113
state: Texas
city: Richmond
country: United States
facility: NGM Clinical Study Site 104
state: Virginia
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 604
state: Victoria
city: Melbourne
country: Australia
facility: NGM Clinical Study Site 613
state: Victoria
Study officials:
affiliation: NGM Biopharmaceuticals, Inc
name: Stephen J Rossi, PharmD
role: STUDY_DIRECTOR
References: