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). (OHANA)

  • STATUS
    Recruiting
  • End date
    Jan 28, 2024
  • participants needed
    280
  • sponsor
    Mirum Pharmaceuticals, Inc.
Updated on 28 October 2022

Summary

This is a two-part randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA). Part 1 is an open-label study 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.

Details
Condition Intrahepatic Cholestasis of Pregnancy
Treatment Placebo, Volixibat
Clinical Study IdentifierNCT04718961
SponsorMirum Pharmaceuticals, Inc.
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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
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