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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Intrahepatic Cholestasis of Pregnancy

In brief

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.

Key facts

Study ID

NCT04718961

Run by

Mirum Pharmaceuticals, Inc.

People needed

4

Starts

2021-01-04

Expected to finish

2022-12-07

Last updated by the study team

2024-08-06

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• The University of Texas Medical Branch - Galveston — Galveston, Texas, United States
• University of Texas Health Science Center — Houston, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• Dunedin Hospital — Dunedin, Otago, New Zealand
• Christchurch Women's Hospital — Christchurch, New Zealand
• Capital & Coast District Health Board, Wellington Regional Hospital — Wellington, New Zealand
• Medway NHS Foundation Trust — Gillingham, Kent, United Kingdom
• Bradford Royal Infirmary — Bradford, West Yorkshire, United Kingdom
• Birmingham Womens and Childrens NHS Foundation Trust — Birmingham, United Kingdom
• University Hospital of Wales — Cardiff, United Kingdom
• St Richard's Hospital — Chichester, United Kingdom
• Barts Health NHS Trust- Whipps Cross University Hospital — London, United Kingdom
• Royal Free London Hospital NHS Foundation Trust — London, United Kingdom
• Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom
• West Middlesex University Hospital — Middlesex, United Kingdom
• The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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