Conditions: Primary Sclerosing Cholangitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 419
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

Detailed description:

Arms:
arm 1: Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks. arm 2: Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks. arm 3: Participants who received cilofexor in blinded phase and had entered the open-label extension (OLE) phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks. arm 4: Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.

Interventions: intervention 1: Cilofexor intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg tablet administered orally once daily intervention 2: Tablet administered orally once daily

Protocol document:
Prot_000.pdf: 























































































































































































































































































SAP_001.pdf: