At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 53 enrolled
Drug / intervention
Cholic Aciddrug
Likely dose
Cholic Acid 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Single Center, Nonrandomized Continuation Study of Cholic Acid Capsules to Treat Subjects With Inborn Errors of Bile Acid Synthesis
In Brief
A Phase 3 clinical trial evaluating Cholic Acid for Bile Acid Synthesis Defect. Completed, enrolled 53 participants across 1 site.
Detailed Summary
The primary purpose of the study is to evaluate the therapeutic efficacy and safety of cholic acid in subjects with identified inborn errors of bile acid synthesis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBile Acid Synthesis Defect
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2010
First PostedSep 2011
Primary CompletionJul 2016
TodayJul 2026
First PostedSep 22, 2011
Enrollment StartJan 1, 2010
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 14.8 years ago
Interventions
Cholic Aciddrug
10-15 mg/kg body weight/day supplied in 50 or 250 mg Cholic Acid Capsules