A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
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.
- Intrahepatic Cholestasis of Pregnancy
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Investigator)
|Participants randomized to this arm will receive volixibat 20mg twice daily.||
|Participants randomized to this arm will receive volixibat 80mg twice daily.||
|Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.||
- Mirum Pharmaceuticals, Inc.
Study ContactClinical Trials Mirum