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

PHASE2TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

January 4, 2021

Primary Completion Date

December 7, 2022

Study Completion Date

December 7, 2022

Conditions
Intrahepatic Cholestasis of Pregnancy
Interventions
DRUG

Volixibat

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

DRUG

Placebo

Capsules matched to study drug minus active substance.

Trial Locations (20)

6021

Dunedin Hospital, Dunedin

Capital & Coast District Health Board, Wellington Regional Hospital, Wellington

8011

Christchurch Women's Hospital, Christchurch

33136

University of Miami, Miami

35294

University of Alabama at Birmingham, Birmingham

43210

The Ohio State University Wexner Medical Center, Columbus

77030

University of Texas Health Science Center, Houston

77555

The University of Texas Medical Branch - Galveston, Galveston

78229

University of Texas Health Science Center at San Antonio, San Antonio

06511

Yale School of Medicine, New Haven

ME7 5NY

Medway NHS Foundation Trust, Gillingham

BD9 6RJ

Bradford Royal Infirmary, Bradford

B15 2TG

Birmingham Womens and Childrens NHS Foundation Trust, Birmingham

CF14 4XW

University Hospital of Wales, Cardiff

PO19 6SE

St Richard's Hospital, Chichester

E11 1NR

Barts Health NHS Trust- Whipps Cross University Hospital, London

NW3 2QG

Royal Free London Hospital NHS Foundation Trust, London

SE 1 7EH

Guy's and St Thomas' NHS Foundation Trust, London

TW7 6AF

West Middlesex University Hospital, Middlesex

Unknown

The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Mirum Pharmaceuticals, Inc.

INDUSTRY