Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
Hepatitis B
Enrollment Eligibility
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 and corticosteroids (oral, intravenous,
or topical), opioids, gabapentin, pregabalin, cholestyramine, rifampicin or fibrates
within 14 days prior to screening.