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Bile Acid Sequestrant

Volixibat for Intrahepatic Cholestasis of Pregnancy (OHANA Trial)

Phase 2
Waitlist Available
Research Sponsored by Mirum Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through to end of treatment, up to 21 weeks

Summary

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.

Eligible Conditions
  • Intrahepatic Cholestasis of Pregnancy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through to end of treatment, up to 21 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through to end of treatment, up to 21 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess the Safety and Tolerability of Volixibat in Participants With ICP
Secondary study objectives
Mean Change in the Weekly Average Worst Daily Itch Score as Measured by the Adult Itch Reported Outcome (ItchRO)

Side effects data

From 2015 Phase 1 trial • 84 Patients • NCT02287779
100%
Diarrhoea
22%
Pyrexia
11%
Proctalgia
11%
Abdominal discomfort
11%
Anorectal discomfort
11%
Tachycardia
11%
Vomiting
11%
Pain
11%
Headache
11%
Dry throat
11%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Volixibat 5 mg BID
Volixibat 10 mg QD
Volixibat 20 mg QD
Volixibat 2-5-10-20 mg QD
Volixibat 30 mg QD
Volixibat 40 mg QD
Volixibat 80-40-20 mg QD

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Volixibat
2015
Completed Phase 1
~90
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Mirum Pharmaceuticals, Inc.Lead Sponsor
31 Previous Clinical Trials
101,733 Total Patients Enrolled
~1 spots leftby Nov 2025
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