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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 is a Phase 2 study that was terminated before completion, run by Cara Therapeutics. The registered enrollment target is 14 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03995212
The ClinicalTrials.gov registry entry for NCT03995212 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cara Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03995212 reports 0 study locations.
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.
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