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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02135536




Registration number
NCT02135536
Ethics application status
Date submitted
8/05/2014
Date registered
12/05/2014
Date last updated
28/03/2017

Titles & IDs
Public title
Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis
Scientific 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
Secondary ID [1] 0 0
14-0104
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Biliary Cirrhosis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - NGM282

Experimental: NGM282 Dose 1 - NGM282 Dose 1

Experimental: NGM282 Dose 2 - NGM282 Dose 2

Experimental: NGM282 Dose 3 - NGM282 Dose 3


Treatment: Other: NGM282
NGM282
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change in plasma ALP from Baseline to Week 12
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24
Timepoint [1] 0 0
12 weeks and 24 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Chronic liver disease of a non-PBC etiology
* Evidence of clinically significant hepatic decompensation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
NGM Clinical Study Site 602 - Sydney
Recruitment hospital [2] 0 0
NGM Clinical Study Site 606 - Sydney
Recruitment hospital [3] 0 0
NGM Clinical Study Site 609 - Sydney
Recruitment hospital [4] 0 0
NGM Clinical Study Site 611 - Sydney
Recruitment hospital [5] 0 0
NGM Clinical Study Site 614 - Brisbane
Recruitment hospital [6] 0 0
NGM Clinical Study Site 607 - Adelaide
Recruitment hospital [7] 0 0
NGM Clinical Study Site 608 - Adelaide
Recruitment hospital [8] 0 0
NGM Clinical Study Site 601 - Melbourne
Recruitment hospital [9] 0 0
NGM Clinical Study Site 613 - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
New Zealand
State/province [7] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
NGM Biopharmaceuticals, Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
NGM Biopharmaceuticals Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen J Rossi, PharmD
Address 0 0
NGM Biopharmaceuticals, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02135536