A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA) (OHANA)
Intrahepatic Cholestasis of Pregnancy
About this trial
This is an interventional treatment trial for Intrahepatic Cholestasis of Pregnancy focused on measuring Pruritus, Itch, Itching, Cholestasis, Bile Acid, Pregnancy, Pregnant, Intrahepatic, Liver, ICP
Eligibility Criteria
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.
Sites / Locations
- University of Alabama at Birmingham
- Yale School of Medicine
- University of Miami
- The Ohio State University Wexner Medical Center
- The University of Texas Medical Branch - Galveston
- University of Texas Health Science Center
- University of Texas Health Science Center at San Antonio
- Dunedin Hospital
- Christchurch Women's Hospital
- Capital & Coast District Health Board, Wellington Regional Hospital
- Medway NHS Foundation Trust
- Bradford Royal Infirmary
- Birmingham Womens and Childrens NHS Foundation Trust
- University Hospital of Wales
- St Richard's Hospital
- Barts Health NHS Trust- Whipps Cross University Hospital
- Royal Free London Hospital NHS Foundation Trust
- Guy's and St Thomas' NHS Foundation Trust
- West Middlesex University Hospital
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Part 1 Arm 1 & Arm 2 - Volixibat 20mg/80mg
Part 2 Arm 1 - Volixibat Selected Dose mg
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.
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.