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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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. (Part 2 only) 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.

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

ArmDescriptionAssigned Intervention
Experimental
Part 1 Arm 1 & Arm 2 - Volixibat 20mg/80mg 		Part 1 Arm 1 - Volixibat 20mg (Experimental) Participants randomized to this arm will receive volixibat 20mg twice daily. Part 1 Arm 2 - Volixibat 80mg (Experimental) Participants randomized to this arm will receive volixibat 80mg twice daily.
  • Drug: Volixibat
    Oral capsules, administered twice daily. Volixibat is an ileal bile acid transporter (IBAT) inhibitor.
    Other names:
    • SHP626
Experimental
Part 2 Arm 1 - Volixibat Selected Dose mg 		Part 2 Arm 1 - Volixibat Selected Dose mg (experimental) Participants randomized to this arm will receive volixibat selected dose (mg) twice daily. 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.
  • Drug: Volixibat
    Oral capsules, administered twice daily. Volixibat is an ileal bile acid transporter (IBAT) inhibitor.
    Other names:
    • SHP626
  • Drug: Placebo
    Capsules matched to study drug minus active substance.

More Details

Status
Terminated
Sponsor
Mirum Pharmaceuticals, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.