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COMPLETEDPHASE2

PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis

PERSEUS: A Phase 2 Proof of Concept Study Investigating the Preliminary Efficacy and Safety of Cenicriviroc in Adult Subjects With Primary Sclerosing Cholangitis (PSC)

NCT02653625•Tobira Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is an open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult participants with Primary Sclerosing Cholangitis (PSC). The main objective of this PoC study is to assess changes in alkaline phosphatase (ALP) both individually and as a group, over 24 weeks of treatment with CVC.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with chronic cholestatic liver disease for at least 6 months
•Clinical diagnosis of Primary Sclerosing Cholangitis (PSC) as evident by chronic cholestasis of more than six months duration with either a consistent magnetic resonance cholangiopancreatography (MRCP)/endoscopic retrograde cholangiopancreatography (ERCP) showing sclerosing cholangitis, or a liver biopsy taken at any time consistent with PSC in the absence of a documented alternative etiology for sclerosing cholangitis. If diagnosis of PSC was made by histology alone, it must require the presence of fibro-obliterative lesions (i.e., onion skin lesions)
•Participants with or without Inflammatory Bowel Disease (IBD) are allowed. If participant has IBD, documented evidence of IBD either by prior endoscopy or in previous medical records, for ≥ 6 months. In addition, participants will be required to enter the study with a Partial Mayo Risk score of 0-3, inclusively
•In participants receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months, and at a dose not greater than 20 mg/kg/day
•Serum ALP greater than 1.5 × upper limit of normal (ULN)
•Ability to understand and sign a written informed consent form (ICF)
•Participants receiving allowed concomitant medications need to be on stable therapy for 28 days prior to the Baseline Visit with the exception of UDCA in which participants need to be on stable therapy for ≥ 3 months

Exclusion Criteria

•Presence of documented secondary sclerosing cholangitis (such as ischemic cholangitis, recurrent pancreatitis, intraductal stone disease, severe bacterial cholangitis, surgical or blunt abdominal trauma, recurrent pyogenic cholangitis, choledocholithiasis, toxic sclerosing cholangitis due to chemical agents, or any other cause of secondary sclerosing cholangitis) on prior clinical investigations
•Small duct PSC
•Presence of percutaneous drain or bile duct stent
•History of cholangiocarcinoma or high clinical suspicion over dominant stricture within 1 year by MRCP/ERCP or clinical judgment
•Ascending cholangitis within 60 days prior to Screening
•Alcohol consumption greater than 21 units/week for males or 14 units/week for females (one unit of alcohol is ½ pint of beer \[285 mL\], 1 glass of spirits \[25 mL\] or 1 glass of wine \[125 mL\])
•Prior or planned liver transplantation
•Presence of alternative causes of chronic liver disease, including alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, autoimmune hepatitis
•History of cirrhosis and/or hepatic impairment (Child-Pugh classes A, B and C) and/or hepatic decompensation including ascites, encephalopathy or variceal bleeding. Participants who show evidence of significant worsening of hepatic function will be excluded
•Participants with fibrosis evidence of cirrhosis, as determined by local transient elastography (TE, e.g., Fibroscan) values of ≥ 13.0 kPa, taken within the last 6 months. If TE has not been conducted within the 6 months prior to screening, then one will be conducted during the screening period and can be used as the Baseline value.
+12 more criteria

Locations (9)

Scripps Clinic

La Jolla, California, United States

University of California, Davis Medical Center

Sacramento, California, United States

Sutter Health, California Pacific Medical Center

San Francisco, California, United States

University of Miami

Miami, Florida, United States

Icahn School of Medicine

New York, New York, United States

University of Calgary, Liver Unit

Calgary, Alberta, Canada

University of Alberta, Zeidler Ledcor Centre

Edmonton, Alberta, Canada

University of Manitoba

Winnipeg, Manitoba, Canada

Toronto University Health Center

Toronto, Ontario, Canada

Key Dates

Start Date

March 14, 2016

Primary Completion Date

August 31, 2017

Completion Date

August 31, 2017

Last Updated

October 1, 2018

Enrollment

ACTUAL participants

Conditions

Primary Sclerosing Cholangitis

Interventions

Cenicriviroc 150 mg

DRUG

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

NCT04753996

Primary Sclerosing CholangitisPSC+1 more

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RECRUITING

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Autoimmune HepatitisPrimary Sclerosing Cholangitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis

Inclusion Criteria

Exclusion Criteria

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