Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus
Public ClinicalTrials.gov record NCT03995212. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03995212
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 14 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 25, 2019 (Actual)
- Primary completion
- Jun 29, 2022 (Actual)
- Completion
- Jun 29, 2022 (Actual)
- Last update posted
- Jul 3, 2023
2019 – 2022
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cara Therapeutics Study Site | Coronado | California | 92118 | — |
| Cara Therapeutics Study Site | Rialto | California | 92377 | — |
| Cara Therapeutics Study Site | San Francisco | California | 94114 | — |
| Cara Therapeutics Study Site | Colorado Springs | Colorado | 80907 | — |
| Cara Therapeutics Study Site | Miami | Florida | 33136 | — |
| Cara Therapeutics Study Site | Plantation | Florida | 33322 | — |
| Cara Therapeutics Study Site | Indianapolis | Indiana | 46202 | — |
| Cara Therapeutics Study Site 2 | Boston | Massachusetts | 02114 | — |
| Cara Therapeutics Study Site | Boston | Massachusetts | 02215 | — |
| Cara Therapeutics Study Site | New York | New York | 10065 | — |
| Cara Therapeutics Study Site | Nashville | Tennessee | 37232 | — |
| Cara Therapeutics Study Site | Arlington | Texas | 76012 | — |
| Cara Therapeutics Study Site | Newport News | Virginia | 23606 | — |
| Cara Therapeutics Study Site | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03995212, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 3, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03995212 live on ClinicalTrials.gov.