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NCT03995212 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus
A Phase 2 study, sponsored by Cara Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT03995212: Clinical Trial Phase 2 study, sponsored by Cara Therapeutics.
NCT03995212 is a Phase 2 study that was terminated before completion, run by Cara Therapeutics. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03995212, a Phase 2 study, was terminated before completion, sponsored by Cara Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of twice-daily (BID) oral CR845 1.0 mg in patients with PBC with moderate-to-severe pruritus. The study includes a 16-week Treatment Period.
Primary Outcome
Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".
Interventions
- DRUG Placebo
- DRUG CR845 1.0 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2022-06-29 |
| Phase | Phase 2 |
Why NCT03995212 stopped before completion
NCT03995212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03995212 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03995212 about?
NCT03995212 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus". This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of twice-daily (BID) oral CR845 1.0 mg in patients with PBC with moderate-to-severe pruritus. The study includes a 16-week Treatment Period.
What is the current status of trial NCT03995212?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2019-06-25. Estimated completion is 2022-06-29.
What interventions are being tested in trial NCT03995212?
The interventions under investigation include: Placebo (DRUG), CR845 1.0 mg (DRUG).
Who is sponsoring clinical trial NCT03995212?
This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03995212's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 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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