NCT04718961

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Mirum Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Intrahepatic Cholestasis of Pregnancy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-04
• Primary completion: 2022-12-07
• Completion: 2022-12-07
• First posted: 2021-01-22
• Last updated: 2024-08-06
• Results posted: 2024-08-06

Locations

20 sites across 3 countries: United States, New Zealand, United Kingdom

Regulatory

• FDA-regulated drug study