Clinical Trial: PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Subjects With Primary Sclerosing Cholangitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: This is a single-arm, open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult subjects 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.

Detailed Summary:
Sponsor: Tobira Therapeutics, Inc.

Current Primary Outcome: Percent change from baseline through Week 24 in serum alkaline phosphatase [ Time Frame: 24 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Tobira Therapeutics, Inc.

Dates:
Date Received: January 8, 2016
Date Started: February 2016
Date Completion: June 2017
Last Updated: April 18, 2016
Last Verified: April 2016