Back to resultsRollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
Primary Purpose
Nonalcoholic Steatohepatitis, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cenicriviroc
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis
Eligibility Criteria
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).
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.
Sites / Locations
- Digestive Health Specialists of the Southeast - Dothan
- Mayo Clinic Hospital
- Adobe Clinical Research, LLC
- Franco Felizarta, MDv
- University of California, San Diego (UCSD)
- Inland Empire Liver Foundation
- University of California, San Diego (UCSD) - Medical Center
- Quest Clinical Research
- Upland Clinical Research
- Island View Gastroenterology Associates
- University of Miami - Schiff Center for Liver Diseases
- Advanced Medical Research
- Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
- Rush University Medical Center
- University of Iowa Hospital and Clinics
- Kansas Medical Clinic PA
- Delta Research Partners, Llc
- Tandem Clinical Research LLC
- Tulane University Medical Center
- Mercy Medical Center - Baltimore, Maryland
- Johns Hopkins University School of Medicine
- Massachusetts General Hospital
- Henry Ford Health System
- Minnesota Gastroenterology, P.A.
- Digestive Health Specialists
- University of Buffalo - Erie County Medical Center
- Carolinas Medical Center
- Duke University Medical Center (DUMC)
- Wake Research Associates, LLC - Raleigh
- PMG Research of Winston-Salem, LLC
- Consultants for Clinical Research - Cincinnati
- Options Health Research, LLC
- ClinSearch LLC
- Gastro One
- Digestive Health Research
- The University of Texas - Health Science Center & Medical School at Houston
- The Texas Liver Institute
- University of Utah
- Virginia Commonwealth University Medical College of Virginia
- Virginia Mason Medical Center
- Swedish Medical Center
- Royal Brisbane Hospital and Women's Hospital
- Central Adelaide Local Health Network Inc - Royal Adelaide Hospital
- Flinders Medical Centre
- Monash Medical Centre
- Austin Health
- UCL Saint Luc Bruxelles
- University Hospital Erasmus (Brussels)
- Antwerp University Hospital (UZA)
- CHU Angers
- Hopital Saint Antoine
- Purpan CHU Toulouse
- Uniklinik RWTH Aachen
- Charite - University Hospital Berlin - Campus Virchow - Hospital
- Universitaetsklinikum Hamburg-Eppendorf - I. Medizinische Klinik und Poliklinik
- Universitaetsklinikum Heidelberg - Innere Medizin IV
- Uniklinik Koeln, Poliklinik fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP)
- Eugastro GmbH
- University Hospital Giessen and Marburg GmbH
- Prince of Wales Hospital
- Policlinico S. Orsola-Malpighi
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
- AOU Policlinico Paolo Giaccone di Palermo
- ID Clinic
- Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.
- Fundacion de Investigacion de Diego
- Hospital Universitario Vall d'Hebron
- Hospital de la Santa Creu i Sant Pau Barcelona
- Hospital General Universitario Gregorio Maranon
- Nottingham NHS Treatment Centre
- Queen Alexandra Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cenicriviroc (CVC) 150 mg
Arm Description
Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
Outcomes
Primary Outcome Measures
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 the treatment. A treatment-emergent AE is an AE that occurs after a participant receives study drug.
Secondary Outcome Measures
Full Information
NCT ID
NCT03059446
First Posted
February 3, 2017
Last Updated
January 4, 2022
Sponsor
Tobira Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03059446
Brief Title
Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
Official Title
Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early due to lack of efficacy based on the results of Part I of the AURORA study.
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
January 5, 2021 (Actual)
Study Completion Date
January 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tobira Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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].
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cenicriviroc (CVC) 150 mg
Arm Type
Experimental
Arm Description
Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
Intervention Type
Drug
Intervention Name(s)
Cenicriviroc
Other Intervention Name(s)
CVC
Intervention Description
Cenicriviroc immediate release tablets
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (AE)
Description
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 the treatment. A treatment-emergent AE is an AE that occurs after a participant receives study drug.
Time Frame
Day 1 until the study was terminated (up to approximately 4 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo B Martins
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Digestive Health Specialists of the Southeast - Dothan
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Adobe Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Franco Felizarta, MDv
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
University of California, San Diego (UCSD)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
University of California, San Diego (UCSD) - Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Upland Clinical Research
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Island View Gastroenterology Associates
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
University of Miami - Schiff Center for Liver Diseases
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Advanced Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kansas Medical Clinic PA
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Delta Research Partners, Llc
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
Country
United States
Facility Name
Tandem Clinical Research LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Tulane University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Mercy Medical Center - Baltimore, Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Gastroenterology, P.A.
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Digestive Health Specialists
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
University of Buffalo - Erie County Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center (DUMC)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Research Associates, LLC - Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Consultants for Clinical Research - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Options Health Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
ClinSearch LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Digestive Health Research
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37090
Country
United States
Facility Name
The University of Texas - Health Science Center & Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Commonwealth University Medical College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Royal Brisbane Hospital and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Central Adelaide Local Health Network Inc - Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
UCL Saint Luc Bruxelles
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
University Hospital Erasmus (Brussels)
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Antwerp University Hospital (UZA)
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
CHU Angers
City
Angers Cedex 09
ZIP/Postal Code
49933
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Purpan CHU Toulouse
City
Toulouse, cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Uniklinik RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Charite - University Hospital Berlin - Campus Virchow - Hospital
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf - I. Medizinische Klinik und Poliklinik
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg - Innere Medizin IV
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Uniklinik Koeln, Poliklinik fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP)
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Eugastro GmbH
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Facility Name
University Hospital Giessen and Marburg GmbH
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Prince of Wales Hospital
City
Shatin
ZIP/Postal Code
Hong Kong
Country
Hong Kong
Facility Name
Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
AOU Policlinico Paolo Giaccone di Palermo
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
ID Clinic
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
927
Country
Puerto Rico
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8022
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau Barcelona
City
Barcelona
ZIP/Postal Code
8026
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Nottingham NHS Treatment Centre
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Queen Alexandra Hospital
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
We'll reach out to this number within 24 hrs