CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5 enrolled
Drug / intervention
Glycocholic Aciddrug
Likely dose
Glycocholic Acid 15mg/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.

Search/NCT01589523
NCT01589523Phase 3Completed
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Conjugated Cholic Acid for the Treatment of Inborn Errors in Bile Acid Synthesis Involving Side-Chain Conjugation

Children's Hospital Medical Center, Cincinnati·interventional·Posted May 2, 2012·Updated Jun 8, 2022

In Brief

A Phase 3 clinical trial evaluating Glycocholic Acid for Bile Acid Synthesis Defect and 2 related conditions. Completed, enrolled 5 participants across 1 site.

Detailed Summary

The purpose of this research study is to determine the way (mechanisms) by which your defect in bile acid handling (metabolism) causes your liver disease or abnormality in absorption of vitamins and the effect of an investigational bile acid therapy (glycocholic acid) on your vitamin absorption and your liver disease. An investigational therapy is one that not approved by the United States Food and Drug Administration (FDA) and is being provided to you under an Investigational New Drug application from the FDA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBile Acid Synthesis Defect, Inborn Error of Bile Acid Metabolism, Inborn Error of Bile Acid Conjugation
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2, 2012
Enrollment StartFeb 1, 2006
Primary CompletionJan 22, 2019
TodayJul 2, 2026
Enrollment to primary: 13.0 yearsPosted 14.2 years ago

Interventions

Glycocholic Aciddrug

10-15mg/kg body weight/day taken orally. Supplied as either liquid or 50mg capsules.