Status:
TERMINATED
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
Lead Sponsor:
Mirum Pharmaceuticals, Inc.
Conditions:
Intrahepatic Cholestasis of Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Female aged ≥18 and ≤45 years with a viable pregnancy.
- Provide signed informed consent as described in the protocol and willing to comply with all study visits and requirements.
- Diagnosis of ICP.
- (Part 2 only) Qualified level of pruritus associated with ICP, during screening.
Exclusion
- At the time of either the screening or baseline visit, decision has already been made to deliver within the next 7 days, for any indication.
- Known non-reassuring fetal status based upon antepartum testing (e.g., NST/CTG or BPP) at or within 7 days before the baseline visit.
- Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life.
- Participating in another ongoing interventional clinical study at screening or planning to participate in another contemporaneous interventional clinical study while participating in this study.
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04718961
Start Date
January 4 2021
End Date
December 7 2022
Last Update
August 6 2024
Active Locations (20)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Yale School of Medicine
New Haven, Connecticut, United States, 06511
3
University of Miami
Miami, Florida, United States, 33136
4
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210