Nonalcoholic SteatohepatitisPhase 2NCT03059446

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

A Phase 2 study testing Cenicriviroc in people with Nonalcoholic Steatohepatitis and Liver Cirrhosis, run by Tobira Therapeutics, Inc. at 71 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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]. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Nonalcoholic Steatohepatitis, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
What is being tested?: Cenicriviroc
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 167 participants
Where: 71 sitesin 11 countries
Study dates: 14 Feb 2017to 5 Jan 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

71 sites in 11 countries.

Country

City, postcode or hospital

71 sites in 11 countries

United States41 sites

Franco Felizarta, MDv
Bakersfield, California, 93301
Mercy Medical Center - Baltimore, Maryland
Baltimore, Maryland, 21202
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Delta Research Partners, Llc
Bastrop, Louisiana, 71220
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Buffalo - Erie County Medical Center
Buffalo, New York, 14215
Carolinas Medical Center
Charlotte, North Carolina, 28204
ClinSearch LLC
Chattanooga, Tennessee, 37421
Rush University Medical Center
Chicago, Illinois, 60612
Consultants for Clinical Research - Cincinnati
Cincinnati, Ohio, 45249
Henry Ford Health System
Detroit, Michigan, 48202
Digestive Health Specialists of the Southeast - Dothan
Dothan, Alabama, 36305
Duke University Medical Center (DUMC)
Durham, North Carolina, 27710
Gastro One
Germantown, Tennessee, 38138
The University of Texas - Health Science Center & Medical School at Houston
Houston, Texas, 77030
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
University of California, San Diego (UCSD)
La Jolla, California, 92037
Digestive Health Research
Lebanon, Tennessee, 37090
Tandem Clinical Research LLC
Marrero, Louisiana, 70072
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, 33136
Tulane University Medical Center
New Orleans, Louisiana, 70112
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Advanced Medical Research
Port Orange, Florida, 32127
Wake Research Associates, LLC - Raleigh
Raleigh, North Carolina, 27612
Inland Empire Liver Foundation
Rialto, California, 92377
Virginia Commonwealth University Medical College of Virginia
Richmond, Virginia, 23249
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, 55114
University of Utah
Salt Lake City, Utah, 84132
The Texas Liver Institute
San Antonio, Texas, 78215
University of California, San Diego (UCSD) - Medical Center
San Diego, California, 92093
Quest Clinical Research
San Francisco, California, 94115
Virginia Mason Medical Center
Seattle, Washington, 98101
Swedish Medical Center
Seattle, Washington, 98104
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
Tampa, Florida, 33606
Kansas Medical Clinic PA
Topeka, Kansas, 66606
Adobe Clinical Research, LLC
Tucson, Arizona, 85712
Options Health Research, LLC
Tulsa, Oklahoma, 74104
Digestive Health Specialists
Tupelo, Mississippi, 38801
Upland Clinical Research
Upland, California, 91786
Island View Gastroenterology Associates
Ventura, California, 93003
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103

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Germany7 sites

Uniklinik RWTH Aachen
Aachen, 52074
Charite - University Hospital Berlin - Campus Virchow - Hospital
Berlin, 13353
Uniklinik Koeln, Poliklinik fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP)
Cologne, 50937
Universitaetsklinikum Hamburg-Eppendorf - I. Medizinische Klinik und Poliklinik
Hamburg, 20246
Universitaetsklinikum Heidelberg - Innere Medizin IV
Heidelberg, 69120
Eugastro GmbH
Leipzig, 4103
University Hospital Giessen and Marburg GmbH
Marburg, 35043

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Australia5 sites

Central Adelaide Local Health Network Inc - Royal Adelaide Hospital
Adelaide, South Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, 5042
Monash Medical Centre
Clayton, Victoria, 3168
Austin Health
Heidelberg, Victoria, 3084
Royal Brisbane Hospital and Women's Hospital
Herston, Queensland, 4029

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Belgium3 sites

University Hospital Erasmus (Brussels)
Brussels, 1070
UCL Saint Luc Bruxelles
Brussels, 1200
Antwerp University Hospital (UZA)
Edegem, 2650

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France3 sites

CHU Angers
Angers, 49933
Hopital Saint Antoine
Paris, 75012
Purpan CHU Toulouse
Toulouse, 31059

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Italy3 sites

Policlinico S. Orsola-Malpighi
Bologna, 40138
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
Milan, 20122
AOU Policlinico Paolo Giaccone di Palermo
Palermo, 90127

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Spain3 sites

Hospital Universitario Vall d'Hebron
Barcelona, 8022
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona, 8026
Hospital General Universitario Gregorio Maranon
Madrid, 28007

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Poland2 sites

ID Clinic
Mysłowice, 41-400
Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.
Wroclaw, 50-349

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United Kingdom2 sites

Nottingham NHS Treatment Centre
Nottingham, NG7 2UH
Queen Alexandra Hospital
Portsmouth, PO6 3LY

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Hong Kong1 site

Prince of Wales Hospital
Shatin, Hong Kong

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Puerto Rico1 site

Fundacion de Investigacion de Diego
San Juan, 927

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About this study

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

Conditions: Nonalcoholic Steatohepatitis, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
Being tested: Cenicriviroc
Medical subject headings: Non-alcoholic Fatty Liver Disease, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CenicrivirocDrug
Also called CVC
Cenicriviroc immediate release tablets

Study groups in NCT03059446
Study group	Role	What they receive
Cenicriviroc (CVC) 150 mg	Experimental	Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years). Receives: Drug: Cenicriviroc

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1 until the study was terminated (up to approximately 4 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 20175 Jan 2021

First posted23 Feb 2017
Study start14 Feb 2017
Primary completion5 Jan 2021
Study completion5 Jan 2021

Why it stopped: This study was terminated early due to lack of efficacy based on the results of Part I of the AURORA study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03059446
Sponsor's protocol ID: 3152-201-002
Other IDs: 2016-004754-15, 2016
Status last verified: Sep 2021
First submitted: 3 Feb 2017
Last updated: 2 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
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All Nonalcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
ClinicalTrials.gov ID: NCT03059446
Acronym / sponsor ID: 3152-201-002
Conditions: Nonalcoholic Steatohepatitis, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated early due to lack of efficacy based on the results of Part I of the AURORA study.
Enrolment: 167 participants (actual)
Lead sponsor: Tobira Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 14 Feb 2017 (actual)
Primary completion: 5 Jan 2021 (actual)
Study completion: 5 Jan 2021 (actual)
First posted: 23 Feb 2017 (actual)
Results: Posted 2 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

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

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CenicrivirocAlso: CVCCenicriviroc immediate release tablets	Drug	Cenicriviroc (CVC) 150 mg

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (AE)
Time frame: Day 1 until the study was terminated (up to approximately 4 years)
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.

Results and safety

Results posted to the registry on 2 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cenicriviroc (CVC) 150 mg	167	0

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (AE)

Time frame: Day 1 until the study was terminated (up to approximately 4 years). Count of participants. Unit: Participants

Measure	Cenicriviroc (CVC) 150 mg n = 167
Value	140

Population analysed: Safety Population included all participants who received at least one dose of study drug.

Adverse events

Time frame: Day 1 until the study was terminated (Up to approximately 4 years). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cenicriviroc (CVC) 150 mg	40 of 167 (24%)	98 of 167 (58.7%)	1 of 167

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Nonalcoholic Steatohepatitis

Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
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Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eduardo B Martins study director

Allergan

71 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cenicriviroc in people with Nonalcoholic Steatohepatitis and Liver Cirrhosis, run by Tobira Therapeutics, Inc. at 71 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Germany, Australia, Belgium, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events (AE) (time frame: Day 1 until the study was terminated (up to approximately 4 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03059446.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.