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

NCT02653625 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-10-01

Study results available
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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.

Conditions

  • Primary Sclerosing Cholangitis

Interventions

DRUG

Cenicriviroc 150 mg

One tablet of CVC 150 mg once daily taken with food in the morning.

Sponsors & Collaborators

  • Tobira Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • J.P. Nicandro · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-14
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02653625 on ClinicalTrials.gov