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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03059446
Ethics application status
Date submitted
3/02/2017
Date registered
23/02/2017
Date last updated
13/01/2021

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 - Cenicriviroc (CVC) 150 mg tablet once daily in the morning with food until CVC is commercially available or the study is terminated.


Treatment: Drugs: Cenicriviroc
Cenicriviroc 150 mg tablet once daily in the morning with food.

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) - An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurs after a participant receives study drug.
Timepoint [1] 0 0
Day 1 until the drug is commercially available or the study is terminated (Approximately 2 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 cirrhoses

- 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 encephalophathy (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
Gender
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-antitrypsis (A1AT) deficiency.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Austria
State/province [24] 0 0
Wels
Country [25] 0 0
Belgium
State/province [25] 0 0
Brussel
Country [26] 0 0
Belgium
State/province [26] 0 0
Bruxelles
Country [27] 0 0
Belgium
State/province [27] 0 0
Edegem
Country [28] 0 0
Brazil
State/province [28] 0 0
Minas Gerais
Country [29] 0 0
Brazil
State/province [29] 0 0
San Paulo
Country [30] 0 0
France
State/province [30] 0 0
Angers Cedex 09
Country [31] 0 0
France
State/province [31] 0 0
Paris
Country [32] 0 0
France
State/province [32] 0 0
Toulouse, cedex 9
Country [33] 0 0
Germany
State/province [33] 0 0
Aachen
Country [34] 0 0
Germany
State/province [34] 0 0
Berlin
Country [35] 0 0
Germany
State/province [35] 0 0
Hamburg
Country [36] 0 0
Germany
State/province [36] 0 0
Heidelberg
Country [37] 0 0
Germany
State/province [37] 0 0
Koeln
Country [38] 0 0
Germany
State/province [38] 0 0
Leipzig
Country [39] 0 0
Germany
State/province [39] 0 0
Marburg
Country [40] 0 0
Hong Kong
State/province [40] 0 0
Shatin
Country [41] 0 0
Israel
State/province [41] 0 0
Tel-Hashomer
Country [42] 0 0
Italy
State/province [42] 0 0
Bologna
Country [43] 0 0
Italy
State/province [43] 0 0
Milano
Country [44] 0 0
Italy
State/province [44] 0 0
Palermo
Country [45] 0 0
Italy
State/province [45] 0 0
Rozzano (MI)
Country [46] 0 0
New Zealand
State/province [46] 0 0
Auckland N
Country [47] 0 0
Poland
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Myslowice
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Poland
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Wroclaw
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Puerto Rico
State/province [49] 0 0
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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Switzerland
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St.Gallen
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United Kingdom
State/province [53] 0 0
Nottingham
Country [54] 0 0
United Kingdom
State/province [54] 0 0
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/show/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/show/NCT03059446