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A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)

NCT ID: NCT04718961

Last Updated: 2024-08-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2022-12-07

Brief Summary

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Part 1 is an open-label randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability of two doses of volixibat. Part 2 is a double-blind, placebo controlled, study designed to evaluate the safety and efficacy of a selected volixibat dose.

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Detailed Description

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Conditions

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Intrahepatic Cholestasis of Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Open-label two arm study (Part 1) followed by a randomized double-blind, placebo controlled, study (Part 2)
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Masking in Part 2 Only

Study Groups

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Part 1 Arm 1 - Volixibat 20mg

Participants randomized to this arm will receive volixibat 20mg twice daily.

Group Type EXPERIMENTAL

Volixibat

Intervention Type DRUG

Oral capsules, administered twice daily. Volixibat is an ileal bile acid transporter (IBAT) inhibitor.

Part 1 Arm 2 - Volixibat 80mg

Participants randomized to this arm will receive volixibat 80mg twice daily.

Group Type EXPERIMENTAL

Volixibat

Intervention Type DRUG

Oral capsules, administered twice daily. Volixibat is an ileal bile acid transporter (IBAT) inhibitor.

Part 2 Arm 1 - Volixibat Selected Dose mg

Participants randomized to this arm will receive volixibat selected dose (mg) twice daily.

Group Type EXPERIMENTAL

Volixibat

Intervention Type DRUG

Oral capsules, administered twice daily. Volixibat is an ileal bile acid transporter (IBAT) inhibitor.

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 Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules matched to study drug minus active substance.

Interventions

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Volixibat

Oral capsules, administered twice daily. Volixibat is an ileal bile acid transporter (IBAT) inhibitor.

Intervention Type DRUG

Placebo

Capsules matched to study drug minus active substance.

Intervention Type DRUG

Other Intervention Names

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SHP626

Eligibility Criteria

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Inclusion Criteria

1. Female aged ≥18 and ≤45 years with a viable pregnancy.
2. Provide signed informed consent as described in the protocol and willing to comply with all study visits and requirements.
3. Diagnosis of ICP.
4. (Part 2 only) Qualified level of pruritus associated with ICP, during screening.

Exclusion Criteria

1. 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.
2. Known non-reassuring fetal status based upon antepartum testing (e.g., NST/CTG or BPP) at or within 7 days before the baseline visit.
3. Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life.
4. Participating in another ongoing interventional clinical study at screening or planning to participate in another contemporaneous interventional clinical study while participating in this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mirum Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Yale School of Medicine

New Haven, Connecticut, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

The University of Texas Medical Branch - Galveston

Galveston, Texas, United States

Site Status

University of Texas Health Science Center

Houston, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Dunedin Hospital

Dunedin, Otago, New Zealand

Site Status

Christchurch Women's Hospital

Christchurch, , New Zealand

Site Status

Capital & Coast District Health Board, Wellington Regional Hospital

Wellington, , New Zealand

Site Status

Medway NHS Foundation Trust

Gillingham, Kent, United Kingdom

Site Status

Bradford Royal Infirmary

Bradford, West Yorkshire, United Kingdom

Site Status

Birmingham Womens and Childrens NHS Foundation Trust

Birmingham, , United Kingdom

Site Status

University Hospital of Wales

Cardiff, , United Kingdom

Site Status

St Richard's Hospital

Chichester, , United Kingdom

Site Status

Barts Health NHS Trust- Whipps Cross University Hospital

London, , United Kingdom

Site Status

Royal Free London Hospital NHS Foundation Trust

London, , United Kingdom

Site Status

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

West Middlesex University Hospital

Middlesex, , United Kingdom

Site Status

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States New Zealand United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2020-003448-96

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VLX-401

Identifier Type: -

Identifier Source: org_study_id

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