A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
Purpose
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.
Condition
- Intrahepatic Cholestasis of Pregnancy
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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. (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. 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized Open-label two arm study (Part 1) followed by a randomized double-blind, placebo controlled, study (Part 2)
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- Masking in Part 2 Only
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1 Arm 1 - Volixibat 20mg |
Participants randomized to this arm will receive volixibat 20mg twice daily. |
|
|
Experimental Part 1 Arm 2 - Volixibat 80mg |
Participants randomized to this arm will receive volixibat 80mg twice daily. |
|
|
Experimental Part 2 Arm 1 - Volixibat Selected Dose mg |
Participants randomized to this arm will receive volixibat selected dose (mg) twice daily. |
|
|
Placebo Comparator Part 2 Arm 2 - Placebo (Placebo Comparator) |
Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily. |
|
More Details
- Status
- Terminated
- Sponsor
- Mirum Pharmaceuticals, Inc.