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NCT01589523 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
Phase 3
Development phase
5
Enrollment target

NCT01589523 is a Phase 3 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 5 participants.

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The verdict

NCT01589523, a Phase 3 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
Phase 3
Development phase
5 participants
Enrollment target

Study 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.

Interventions

  • DRUG Glycocholic Acid

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2006-02
Est. Completion 2019-01-22
Phase Phase 3

What the Registry Record Tells You About NCT01589523

The ClinicalTrials.gov registry entry for NCT01589523 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Glycocholic Acid is the first listed.

NCT01589523 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01589523 about?

NCT01589523 is a clinical study titled "GlycoCholic Acid Treatment for Patients With Inborn Errors in Bile Acid Synthesis". 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 ...

What is the current status of trial NCT01589523?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2006-02. Estimated completion is 2019-01-22.

What interventions are being tested in trial NCT01589523?

The interventions under investigation include: Glycocholic Acid (DRUG).

Who is sponsoring clinical trial NCT01589523?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.