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GlycoCholic Acid Treatment for Patients With Inborn Errors in Bile Acid Synthesis

NCT01589523 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-06-08

Study results available
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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.

Conditions

  • Bile Acid Synthesis Defect
  • Inborn Error of Bile Acid Metabolism
  • Inborn Error of Bile Acid Conjugation

Interventions

DRUG

Glycocholic Acid

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

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Kenneth D. Setchell, Ph.D. · Children's Hospital Medical Center, Cincinnati

  • James E. Heubi, M.D. · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Week
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2019-01-22
Completion
2019-01-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01589523 on ClinicalTrials.gov