Clinical trial NCT03059446: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis
Liver Cirrhosis
Non-alcoholic Fatty Liver Disease
Lead sponsor: Tobira Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 \[NCT03028740\].


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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (AE)
timeFrame: Day 1 until the study was terminated (up to approximately 4 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast - Dothan
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC
state: Arizona
city: Bakersfield
country: United States
facility: Franco Felizarta, MDv
state: California
city: La Jolla
country: United States
facility: University of California, San Diego (UCSD)
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: San Diego
country: United States
facility: University of California, San Diego (UCSD) - Medical Center
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Upland
country: United States
facility: Upland Clinical Research
state: California
city: Ventura
country: United States
facility: Island View Gastroenterology Associates
state: California
city: Miami
country: United States
facility: University of Miami - Schiff Center for Liver Diseases
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research
state: Florida
city: Tampa
country: United States
facility: Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
city: Topeka
country: United States
facility: Kansas Medical Clinic PA
state: Kansas
city: Bastrop
country: United States
facility: Delta Research Partners, Llc
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research LLC
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center - Baltimore, Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Paul
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: Tupelo
country: United States
facility: Digestive Health Specialists
state: Mississippi
city: Buffalo
country: United States
facility: University of Buffalo - Erie County Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center (DUMC)
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC - Raleigh
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research - Cincinnati
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research, LLC
state: Oklahoma
city: Chattanooga
country: United States
facility: ClinSearch LLC
state: Tennessee
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Lebanon
country: United States
facility: Digestive Health Research
state: Tennessee
city: Houston
country: United States
facility: The University of Texas - Health Science Center & Medical School at Houston
state: Texas
city: San Antonio
country: United States
facility: The Texas Liver Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical College of Virginia
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Herston
country: Australia
facility: Royal Brisbane Hospital and Women's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Central Adelaide Local Health Network Inc - Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Brussel
country: Belgium
facility: UCL Saint Luc Bruxelles
city: Bruxelles
country: Belgium
facility: University Hospital Erasmus (Brussels)
city: Edegem
country: Belgium
facility: Antwerp University Hospital (UZA)
city: Angers Cedex 09
country: France
facility: CHU Angers
city: Paris
country: France
facility: Hopital Saint Antoine
city: Toulouse, cedex 9
country: France
facility: Purpan CHU Toulouse
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
city: Berlin
country: Germany
facility: Charite - University Hospital Berlin - Campus Virchow - Hospital
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf - I. Medizinische Klinik und Poliklinik
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg - Innere Medizin IV
city: Koeln
country: Germany
facility: Uniklinik Koeln, Poliklinik fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP)
city: Leipzig
country: Germany
facility: Eugastro GmbH
city: Marburg
country: Germany
facility: University Hospital Giessen and Marburg GmbH
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
city: Palermo
country: Italy
facility: AOU Policlinico Paolo Giaccone di Palermo
city: Myslowice
country: Poland
facility: ID Clinic
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Nottingham
country: United Kingdom
facility: Nottingham NHS Treatment Centre
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
Study officials:
affiliation: Allergan
name: Eduardo B Martins
role: STUDY_DIRECTOR
References: