- A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis — Recruiting • Phase II • Gastroenterology • NCT05050136.
- The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of….
- Sponsor: Mirum Pharmaceuticals, Inc.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.
- : * Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study * Male or female, age ≥18 years at the screening visit * Confirmed diagnosis of PBC in line with the AASLD guidelines * UDCA, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria * Qualified pruritus associated with PBC as assessed by Adult ItchRO
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.