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NCT02653625 · ClinicalTrials.gov registry record · Phase 2
PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis
A Phase 2 study, sponsored by Tobira Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT02653625: Completed Phase 2 study, sponsored by Tobira Therapeutics.
NCT02653625 is a Phase 2 study that has completed, run by Tobira Therapeutics. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02653625, a Phase 2 study, has completed, sponsored by Tobira Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study 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.
Primary Outcome
ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease. The percent change from Baseline was defined as 100\*(value at each visit - Baseline value)/Baseline value. The Baseline value was defined as the last non-missing value on or before the Baseline visit (Day 1). A negative percentage change from baseline indicates an improvement.
Interventions
- DRUG Cenicriviroc 150 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-03-14 |
| Est. Completion | 2017-08-31 |
| Phase | Phase 2 |
What the finished NCT02653625 record still lists
NCT02653625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Cenicriviroc 150 mg is the first listed.
NCT02653625 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02653625 about?
NCT02653625 is a clinical study titled "PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis". 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.
What is the current status of trial NCT02653625?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2016-03-14. Estimated completion is 2017-08-31.
What interventions are being tested in trial NCT02653625?
The interventions under investigation include: Cenicriviroc 150 mg (DRUG).
Who is sponsoring clinical trial NCT02653625?
This trial is sponsored by Tobira Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02653625's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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