Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis
NCT02943447 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71
Last updated 2020-09-22
Summary
The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary biliary cholangitis (PBC).
Conditions
Interventions
- DRUG
-
Cilofexor
Tablet(s) administered orally once daily, with food
- DRUG
-
Placebo to match cilofexor
Tablet(s) administered orally once daily, with food
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-01
- Primary Completion
- 2019-09-04
- Completion
- 2019-09-04
- FDA Drug
- Yes
Countries
- United States
- Austria
- Canada
- United Kingdom
Study Locations
More Related Trials
-
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
NCT06016842 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA
NCT03742973 ·Status: TERMINATED ·Phase: PHASE2
-
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
NCT02808312 ·Status: COMPLETED ·Phase: PHASE1
-
An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
NCT04950764 ·Status: COMPLETED ·Phase: PHASE1
-
CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)
NCT05896124 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC
NCT04024813 ·Status: TERMINATED ·Phase: PHASE2
-
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
NCT02308111 ·Status: TERMINATED ·Phase: PHASE4
-
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
NCT02955602 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
NCT04526665 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
NCT06447168 ·Status: RECRUITING
-
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
NCT05104853 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
NCT03124108 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
NCT05627362 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
NCT02966834 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)
NCT04047160 ·Status: COMPLETED ·Phase: PHASE1
-
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
NCT06488911 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus
NCT01899703 ·Status: COMPLETED ·Phase: PHASE2
-
Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary Cholangitis
NCT03668145 ·Status: UNKNOWN ·Phase: NA
-
Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis
NCT03112681 ·Status: COMPLETED ·Phase: PHASE2
-
Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders
NCT02937012 ·Status: UNKNOWN ·Phase: PHASE3
-
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
NCT04594694 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
NCT06699121 ·Status: RECRUITING ·Phase: PHASE2
-
Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)
NCT02609048 ·Status: TERMINATED ·Phase: PHASE2
-
Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease
NCT04761848 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
NCT06383403 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3