NCT04060147

Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis

A Proof-of-Concept, Open-Label Study Evaluating the Safety and Tolerability of Cilofexor in Subjects With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.

Conditions

• Primary Sclerosing Cholangitis
• Compensated Cirrhosis

Interventions

Type	Name	Description
DRUG	Cilofexor	Tablets administered orally once daily

Timeline

• Start date: 2019-10-17
• Primary completion: 2021-09-02
• Completion: 2021-09-02
• First posted: 2019-08-16
• Last updated: 2023-07-27
• Results posted: 2023-07-27

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study