TerminatedPhase 2

Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus

Stopped: Slow enrollment due primarily to Covid-19

United States14 participantsStarted 2019-06-25

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: To be eligible for inclusion into the study, a patient must meet the following criteria: * Confirmed diagnosis of PBC; * If currently taking ursodeoxycholic acid (UDCA), should be on stable dose for \>12 weeks prior to screening and plan on continuing to take UDCA throughout the study; * If previously taking UDCA, should have discontinued its use \>12 weeks prior to screening; * Self-reports experiencing daily or near-daily pruritus during the month prior to screening; * Prior to randomization has a mean baseline WI-NRS score indicative of moderate to severe pruritus. Key Exclusion Criteria: A patient will be excluded from the study if any of the following criteria are met: * Presence of Child-Pugh Class C decompensated cirrhosis at screening; * Itching secondary to biliary obstruction; * History or presence of hepatocellular carcinoma, hepatic abscess, or acute portal vein thrombosis; * Current placement on liver transplantation list with anticipated liver transplant during the course of the study or current Model for End-stage Liver Disease (MELD) score ≥15; * Alanine aminotransferase or aspartate aminotransferase \>5 × upper limit of normal at screening, or within 2 months prior to screening; * Anticipates receiving an opioid antagonist (eg, naloxone, naltrexone) or opioid-mixed agonist-antagonist (eg, buprenorphine, nalbuphine) from the start of screening through the end of the Treatment Period; * New or change of treatment with antihistamines…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline to Week 16 with respect to the weekly mean of the daily 24-hour Worst Itching Intensity Numeric Rating Scale (WI-NRS) score.

Timeframe: Baseline, Week 16

Trial details

NCT IDNCT03995212

SponsorCara Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-29

View on ClinicalTrials.gov More Cholestatic Pruritus trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.