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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 at least one month after delivery.
Awards & highlights

Summary

This trial is testing a new drug to treat a pregnancy complication called ICP, which causes elevated levels of bile acids. The first part of the trial will test for safety and tolerability of the drug at two different doses. The second part will be a placebo-controlled study to see if the drug is effective.

Eligible Conditions
  • Intrahepatic Cholestasis of Pregnancy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at least one month after delivery.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at least one month after delivery. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in serum bile acids
Secondary outcome measures
Mean change in the weekly average worst daily itch score as measured by the Adult Itch Reported Outcome (ItchRO)
Proportion of participants experiencing one or more of adverse perinatal outcomes
Safety endpoint: The incidence of adverse events

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

2Treatment groups
Experimental Treatment
Group I: Part 2 Arm 1 - Volixibat Selected Dose mgExperimental Treatment2 Interventions
Part 2 Arm 1 - Volixibat Selected Dose mg (experimental) Participants randomized to this arm will receive volixibat selected dose (mg) twice daily. Part 2 Arm 2 - Placebo (Placebo Comparator) Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Group II: Part 1 Arm 1 & Arm 2 - Volixibat 20mg/80mgExperimental Treatment1 Intervention
Part 1 Arm 1 - Volixibat 20mg (Experimental) Participants randomized to this arm will receive volixibat 20mg twice daily. Part 1 Arm 2 - Volixibat 80mg (Experimental) Participants randomized to this arm will receive volixibat 80mg 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
29 Previous Clinical Trials
1,642 Total Patients Enrolled
~1 spots leftby Jul 2025