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Phase 2a/2b

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

  • Study HIC#:2000029456
  • Last Updated:01/11/2022

The purpose of this clinical research study is to evaluate the efficacy, safety and tolerability of the study medicine, volixibat, in patients with Intrahepatic cholestasis of pregnancy (ICP) and elevated serum bile acid concentrations.

  • Age18 years - 45 years
  • GenderFemale only
  • Start Date02/27/2021
  • End Date01/31/2024

Trial Purpose and Description

The purpose of this clinical research study is to evaluate the efficacy, safety and tolerability of the study medicine, volixibat, in patients with Intrahepatic cholestasis of pregnancy (ICP) and elevated serum bile acid concentrations.

Eligibility Criteria

Inclusion Criteria:

  1. Female aged ≥18 and ≤45 years with a viable pregnancy.
  2. Provide signed informed consent as described in the protocol and willing to comply with all study visits and requirements.
  3. Diagnosis of ICP.
  4. Qualified level of pruritus associated with ICP, during screening.

Exclusion Criteria:

  1. 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.
  2. Known non-reassuring fetal status based upon antepartum testing (e.g., NST/CTG or BPP) at or within 7 days before the baseline visit.
  3. Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life.
  4. 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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