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NCT04718961 · ClinicalTrials.gov registry record · Phase 2
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
A Phase 2 study, sponsored by Mirum Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT04718961: Clinical Trial Phase 2 study, sponsored by Mirum Pharmaceuticals.
NCT04718961 is a Phase 2 study that was terminated before completion, run by Mirum Pharmaceuticals. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04718961, a Phase 2 study, was terminated before completion, sponsored by Mirum Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
Part 1 is an open-label randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability of two doses of volixibat. Part 2 is a double-blind, placebo controlled, study designed to evaluate the safety and efficacy of a selected volixibat dose.
Primary Outcome
To assess the safety and tolerability of volixibat in participants with ICP on the basis of the following endpoints: Proportion of participants experiencing one or more of the following: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), events of clinical interest (ECIs), and adverse events (AEs) that lead to discontinuation of study drugs. Clinically significant laboratory abnormalities
Interventions
- DRUG Placebo
- DRUG Volixibat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-01-04 |
| Est. Completion | 2022-12-07 |
| Phase | Phase 2 |
Why NCT04718961 stopped before completion
NCT04718961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04718961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04718961 about?
NCT04718961 is a clinical study titled "A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)". Part 1 is an open-label randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability of two doses of volixibat. Part 2 is a double-blind, placebo controlled, study designed to evaluate...
What is the current status of trial NCT04718961?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2021-01-04. Estimated completion is 2022-12-07.
What interventions are being tested in trial NCT04718961?
The interventions under investigation include: Placebo (DRUG), Volixibat (DRUG).
Who is sponsoring clinical trial NCT04718961?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04718961's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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