Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis

Liver Cirrhosis Clinical Trial

Official title:

Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03059446
• Other study ID #: 3152-201-002
• Secondary ID: 2016-004754-15
• Status: Terminated
• Phase: Phase 2
• Start date: February 14, 2017
• Est. completion date: January 5, 2021

Study information

• Verified date: September 2021
• Source: Tobira Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 167
• Est. completion date: January 5, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Cirrhosis
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• Cenicriviroc
Cenicriviroc immediate release tablets

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Tobira Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Hong Kong,  Italy,  Poland,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 until the study was terminated (up to approximately 4 years)