Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Cholestatic Pruritus
In brief
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.
Key facts
- Study ID
- NCT03995212
- Run by
- Cara Therapeutics, Inc.
- People needed
- 14
- Starts
- 2019-06-25
- Expected to finish
- 2022-06-29
- Last updated by the study team
- 2023-07-03
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cara Therapeutics Study Site — Coronado, California, United States
- Cara Therapeutics Study Site — Rialto, California, United States
- Cara Therapeutics Study Site — San Francisco, California, United States
- Cara Therapeutics Study Site — Colorado Springs, Colorado, United States
- Cara Therapeutics Study Site — Miami, Florida, United States
- Cara Therapeutics Study Site — Plantation, Florida, United States
- Cara Therapeutics Study Site — Indianapolis, Indiana, United States
- Cara Therapeutics Study Site 2 — Boston, Massachusetts, United States
- Cara Therapeutics Study Site — Boston, Massachusetts, United States
- Cara Therapeutics Study Site — New York, New York, United States
- Cara Therapeutics Study Site — Nashville, Tennessee, United States
- Cara Therapeutics Study Site — Arlington, Texas, United States
- Cara Therapeutics Study Site — Newport News, Virginia, United States
- Cara Therapeutics Study Site — Morgantown, West Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.