- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04718961
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA) (OHANA)
A Phase 2a/2b Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in Adult Women With Intrahepatic Cholestasis of Pregnancy and Elevated Serum Bile Acid Concentrations (OHANA).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Christchurch, New Zealand, 8011
- Christchurch Women's Hospital
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Wellington, New Zealand, 6021
- Capital & Coast District Health Board, Wellington Regional Hospital
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Otago
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Dunedin, Otago, New Zealand, 6021
- Dunedin Hospital
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Birmingham, United Kingdom, B15 2TG
- Birmingham Womens and Childrens NHS Foundation Trust
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Cardiff, United Kingdom, CF14 4XW
- University Hospital of Wales
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Chichester, United Kingdom, PO19 6SE
- St Richard's Hospital
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London, United Kingdom, E11 1NR
- Barts Health NHS Trust- Whipps Cross University Hospital
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London, United Kingdom, NW3 2QG
- Royal Free London Hospital NHS Foundation Trust
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London, United Kingdom, SE 1 7EH
- Guy's and St Thomas' NHS Foundation Trust
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Middlesex, United Kingdom, TW7 6AF
- West Middlesex University Hospital
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Newcastle Upon Tyne, United Kingdom
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
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Kent
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Gillingham, Kent, United Kingdom, ME7 5NY
- Medway NHS Foundation Trust
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West Yorkshire
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Bradford, West Yorkshire, United Kingdom, BD9 6RJ
- Bradford Royal Infirmary
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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Connecticut
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New Haven, Connecticut, United States, 06511
- Yale School of Medicine
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University Wexner Medical Center
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Texas
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Galveston, Texas, United States, 77555
- The University of Texas Medical Branch - Galveston
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Houston, Texas, United States, 77030
- University of Texas Health Science Center
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
- (Part 2 only) Qualified level of pruritus associated with ICP, during screening.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Part 1 Arm 1 & Arm 2 - Volixibat 20mg/80mg
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. |
Oral capsules, administered twice daily.
Volixibat is an ileal bile acid transporter (IBAT) inhibitor.
Other Names:
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EXPERIMENTAL: Part 2 Arm 1 - Volixibat Selected Dose mg
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. |
Oral capsules, administered twice daily.
Volixibat is an ileal bile acid transporter (IBAT) inhibitor.
Other Names:
Capsules matched to study drug minus active substance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change in serum bile acids
Time Frame: Through to end of treatment, up to 21 weeks
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Part 1: To assess the safety and tolerability of volixibat in participants with ICP on the basis of the following endpoints Part 2: To assess the efficacy of volixibat on the reduction of elevated sBA concentrations in participants with ICP |
Through to end of treatment, up to 21 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Mean change in the weekly average worst daily itch score as measured by the Adult Itch Reported Outcome (ItchRO)
Time Frame: Through to end of treatment, up to 21 weeks
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Through to end of treatment, up to 21 weeks
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Proportion of participants experiencing one or more of adverse perinatal outcomes
Time Frame: At least one month after delivery.
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At least one month after delivery.
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Safety endpoint: The incidence of adverse events
Time Frame: Through to end of treatment, up to 25 weeks
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Through to end of treatment, up to 25 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VLX-401
- 2020-003448-96 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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