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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

OHANA Trial 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

OHANA Trial 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

OHANA 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many localities are currently offering access to this clinical experiment?

"Presently, 8 different medical facilities are involved in this trial. These sites can be found in locations like San Antonio, Birmingham and Galveston amongst several other cities. It is beneficial for potential participants to select the clinic nearest them to limit travel requirements."

Answered by AI

Does this research study offer participation to those over the age of 65?

"As stated by the admission criteria, only individuals aged 18 to 45 years old are allowed to take part in this trial."

Answered by AI

Is there still availability for individuals to participate in this research?

"Prospective enrollees are currently being sought out. The clinical trial was officially initiated on the 4th of January 2021 and underwent its most recent edit on October 5th 2022, as indicated by clinicaltrials.gov."

Answered by AI

What safety risks are associated with taking Volixibat?

"There is evidence of Volixibat's safety, yet no proof that it works as intended, so the team at Power assigned a score of 2 to its risk profile."

Answered by AI

Does this research represent a unique approach to the field?

"At the present time, 3 ongoing studies concerning Volixibat are being conducted in 50 cities and 6 countries. The original study, backed by Mirum Pharmaceuticals, Inc., was launched in 2020 with 200 participants and has since progressed to Phase 2 drug approval. Since then a total of 18322 trials have been executed."

Answered by AI

What is the aggregate participation rate of this clinical trial?

"Mirum Pharmaceuticals, Inc. are responsible for managing this medical trial and have identified a requirement of 280 suitable patients to participate in the research. Locations across Texas and Alabama such as University of Texas Health Science Center at San Antonio and University of Alabama at Birmingham will be running the study."

Answered by AI

Could I be admitted to this medical research endeavor?

"Eligibility criteria for this medical trial includes intrahepatic cholestasis of pregnancy and being aged between 18-45. The goal is to enrol 280 patients."

Answered by AI

Have any prior examinations been conducted involving Volixibat?

"In 2020, the first clinical trial of Volixibat was conducted at Universitätsklinikum Schleswig-Holstein - Campus Kiel. Since then, 18322 trials have been finished and 3 remain active; most are being performed in San Antonio, Texas."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
2021. "A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04718961.
~1 spots leftby Apr 2025
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