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The REPLACE Registry for Cholbam® (Cholic Acid)

NCT03115086 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2023-10-02

No results posted yet for this study

Summary

This is a prospective, observational, non-interventional patient registry study designed to document product safety and effectiveness outcomes for 10 years in patients treated with Cholbam, including those who have been using Cholbam for at least 30 days (existing users) and those who are first-time initiators of Cholbam.

Conditions

  • Bile Acid Synthesis Disorders

Interventions

DRUG

Cholbam

Cholbam prescribed according to the approved label.

Sponsors & Collaborators

  • Mirum Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Sagar A Vaidya, MD, PhD · Vice President, Clinical Development

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-10
Primary Completion
2038-07-31
Completion
2039-07-31
FDA Drug
Yes

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 NCT03115086 on ClinicalTrials.gov