A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
(OHANA Trial)
Recruiting in Palo Alto (17 mi)
+27 other locations
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Mirum Pharmaceuticals, Inc.
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing volixibat, a medication for pregnant women with a liver condition that causes high bile acid levels. The medication aims to lower these levels to reduce symptoms and risks.
Research Team
Eligibility Criteria
Inclusion Criteria
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.
See 1 more
Treatment Details
Interventions
- Placebo (Other)
- Volixibat (Bile Acid Sequestrant)
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2 Arm 1 - Volixibat Selected Dose mgExperimental Treatment2 Interventions
Participants randomized to this arm will receive volixibat selected dose (mg) twice daily.
Group II: Part 1 Arm 2 - Volixibat 80mgExperimental Treatment1 Intervention
Participants randomized to this arm will receive volixibat 80mg twice daily.
Group III: Part 1 Arm 1 - Volixibat 20mgExperimental Treatment1 Intervention
Participants randomized to this arm will receive volixibat 20mg twice daily.
Group IV: Part 2 Arm 2 - Placebo (Placebo Comparator)Placebo Group1 Intervention
Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at San AntonioSan Antonio, TX
University of Texas Health Science Center at San AntonioSan Antonio, TX
The University of Texas Medical Branch - GalvestonGalveston, TX
University of Texas Health Science CenterHouston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Mirum Pharmaceuticals, Inc.
Lead Sponsor
Trials
32
Patients Recruited
102,000+