Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary … (NCT03995212) | Clinical Trial Compass
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 range18 Years – 80 Years
SexALL
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…
What they're measuring
1
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.