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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03059446




Registration number
NCT03059446
Ethics application status
Date submitted
3/02/2017
Date registered
23/02/2017
Date last updated
2/02/2022

Titles & IDs
Public title
Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
Scientific title
Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
Secondary ID [1] 0 0
2016-004754-15
Secondary ID [2] 0 0
3152-201-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis 0 0
Liver Cirrhosis 0 0
Non-alcoholic Fatty Liver Disease 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
Cancer 0 0 0 0
Liver
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cenicriviroc

Experimental: Cenicriviroc (CVC) 150 mg - Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).


Treatment: Drugs: Cenicriviroc
Cenicriviroc immediate release tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (AE)
Timepoint [1] 0 0
Day 1 until the study was terminated (up to approximately 4 years)

Eligibility
Key inclusion criteria
* Successful completion of both Treatment Period 1 and Treatment Period 2, of the CENTAUR Study (652-2-203), including a Year 2 liver biopsy.
* Completed the AURORA study (3152-301-002) as a result of reaching an adjudicated liver-related clinical outcome in Part 1 or Part 2 of the study of:
* Histopathological progression to cirrhosis
* Model for end-stage liver disease (MELD) score = 15
* Ascites (requiring intervention, ie, large volume paracentesis = 1L or initiation of a diuretic)
* Hospitalization (as defined by a stay of = 24 hours) for onset of variceal bleed, hepatic encephalopathy (defined by a West Haven Stage of = 2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis with positive ascitic fluid bacterial culture).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior or planned liver transplantation
* Other know causes of chronic liver disease such as: Alcoholic liver disease, Primary biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis, Wilson's disease, hemochromatosis, or iron overload, or Alpha-1 antitrypsin (A1AT) deficiency.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/01/2021
Sample size
Target
Accrual to date
Final
167
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Brisbane Hospital and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Central Adelaide Local Health Network Inc - Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [5] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Florida
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Illinois
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Iowa
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Kansas
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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New York
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North Carolina
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Ohio
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Oklahoma
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Tennessee
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Texas
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Utah
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Virginia
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United States of America
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Washington
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Belgium
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Brussel
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Belgium
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Bruxelles
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Belgium
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Edegem
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France
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Angers Cedex 09
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France
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Paris
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France
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Toulouse, cedex 9
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Koeln
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Germany
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Leipzig
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Germany
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Marburg
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Hong Kong
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Shatin
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Italy
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Bologna
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Italy
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Milano
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Italy
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Palermo
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Poland
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Myslowice
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Poland
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Wroclaw
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Puerto Rico
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San Juan
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Spain
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Barcelona
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Spain
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Madrid
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United Kingdom
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Nottingham
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United Kingdom
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Portsmouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tobira Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in either the CENTAUR study 652-2-203 \[NCT02217475\] or the AURORA study \[NCT03028740\].
Trial website
https://clinicaltrials.gov/study/NCT03059446
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eduardo B Martins
Address 0 0
Allergan
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03059446