These trials completed more than 12 months ago and should have reported results. Some have, some have not.
These trials are not yet due to report results: some are ongoing, some completed within the past 12 months.
These trials have problematic data on the registry. Details why »
|Status||Trial ID||Title||Completion date||Category|
|Reported results||2007-001424-12||A Study of INT-747 (6-ECDCA) Monotherapy in Patients with Primary Biliary Cirrhosis||2017-09-25||due-trials|
|Listed as ongoing, but also has a completion date and reported results||2007-001425-10||A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis||2011-01-19||bad-data|
|Not reported||2010-023241-29||A Pilot Study to Evaluate the Safety, Tolerability and Efficacy of Obeticholic Acid (INT-747) for the Treatment of Portal Hypertension (PESTO)||2014-02-20||due-trials|
|Listed as ongoing, but also has a completion date||2011-004728-36||A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis||2018-12-27||bad-data|
|Ongoing, reported early||2014-002205-38||A Phase 2, Randomized, Double-Blind, Placebo-Controlled,Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects with Primary Sclerosing Cholangitis||not-yet-due|
|Ongoing||2014-004693-42||A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia||not-yet-due|
|Ongoing||2014-005012-42||A Phase 3b, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis||not-yet-due|
|Ongoing||2015-002560-16||A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis||not-yet-due|
|Ongoing||2017-000474-11||A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepa...||not-yet-due|
|Ongoing||2017-001762-13||A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Moderate to Severe Hepatic...||not-yet-due|