Trials / Active Not Recruiting
Active Not RecruitingNCT03115086
The REPLACE Registry for Cholbam® (Cholic Acid)
A Prospective, Observational, Non-Interventional, Post-Marketing, Patient Registry to Collect Data on Routine Clinical Care in Patients Treated With Cholbam® (Cholic Acid)
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 55 (estimated)
- Sponsor
- Mirum Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
No experimental intervention is involved. Patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cholbam | Cholbam prescribed according to the approved label. |
Timeline
- Start date
- 2017-07-10
- Primary completion
- 2038-07-01
- Completion
- 2039-07-01
- First posted
- 2017-04-14
- Last updated
- 2023-10-02
Locations
23 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03115086. Inclusion in this directory is not an endorsement.