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NCT00007020 · ClinicalTrials.gov registry record · Phase 3

Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid

A Phase 3 study of Adrenoleukodystrophy and Cholestasis, sponsored by Mirum Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
85
Enrollment target
1
Study location

NCT00007020 is a Phase 3 study of Adrenoleukodystrophy and Cholestasis that has completed, run by Mirum Pharmaceuticals. The registered enrollment target is 85 participants, below the 2,207-participant average among 6 other Adrenoleukodystrophy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00007020, a Phase 3 study of Adrenoleukodystrophy and Cholestasis, has completed, sponsored by Mirum Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
85 participants
Enrollment target
1
Study location

Study Summary

OBJECTIVES: I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate treatment to patients with identified inborn errors of bile acid synthesis and metabolism II. To assess the safety and tolerability of cholic acid

Interventions

  • DRUG Cholic Acids

Study Locations (1)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 85 participants
Start Date 1992-01
Est. Completion 2009-12
Phase Phase 3

Sponsor

Mirum Pharmaceuticals

28 total trials

What the Registry Record Tells You About NCT00007020

The ClinicalTrials.gov registry entry for NCT00007020 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,207-participant average among 6 other Adrenoleukodystrophy trials with a reported enrollment target (96% lower). The listed sponsor is Mirum Pharmaceuticals, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Adrenoleukodystrophy appearing as the primary indexed condition, and to 1 intervention - of which Cholic Acids is the first listed.

NCT00007020 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT00007020 about?

NCT00007020 is a clinical study titled "Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid". OBJECTIVES: I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate treatment to patients with identified inborn errors of bile acid synthesis and metabolism II. To assess the safety and tolerability of cholic acid

What is the current status of trial NCT00007020?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 85 participants. The study started on 1992-01. Estimated completion is 2009-12.

What conditions does trial NCT00007020 study?

This clinical trial studies the following conditions: Adrenoleukodystrophy, Cholestasis, Infantile Refsum's Disease, Zellweger Syndrome, Peroxisomal Disorders.

What interventions are being tested in trial NCT00007020?

The interventions under investigation include: Cholic Acids (DRUG).

Who is sponsoring clinical trial NCT00007020?

This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00007020 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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