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

Phase 2 Terminated 4 enrolled Mirum Pharmaceuticals, Inc.

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2021-01-04
Primary completion: 2022-12-07
Completion: 2022-12-07

Outcome

Outcome not reported

Stopped (Enrollment): “Due to company's assessment of enrollment feasibility.”

Publications

Ovadia C, Stone S, Sibai B, Nunes T, Mogul DB, Krishnaswami J, Kahng J, Li F, Warsi QA, Chien E, Vig P, Williamson C. Efficacy, Safety and Tolerability of Volixibat, an IBAT Inhibitor, in Patients With Intrahepatic Cholestasis of Pregnancy. Liver Int. 2026 Mar;46(3):e70523. doi: 10.1111/liv.70523.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Volixibat	Unknown	20 mg	Oral
Subject	Volixibat	Unknown	80 mg	Oral