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

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.

Timeline

Start

2019-06-25

Primary completion

2022-06-29

Completion

2022-06-29

Outcome

Outcome not reported

Stopped (Enrollment): “Slow enrollment due primarily to Covid-19”

Drugs

Indications