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Purpose

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.

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. 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
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Volixibat 20mg 		Participants randomized to this arm will receive volixibat 20mg twice daily.
  • Drug: Volixibat
    Oral capsules, administered twice daily. Volixibat is an apical sodium-dependent bile acid transporter (ASBT) inhibitor.
    Other names:
    • SHP626
Experimental
Volixibat 80mg 		Participants randomized to this arm will receive volixibat 80mg twice daily.
  • Drug: Volixibat
    Oral capsules, administered twice daily. Volixibat is an apical sodium-dependent bile acid transporter (ASBT) inhibitor.
    Other names:
    • SHP626
Placebo Comparator
Placebo 		Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
  • Drug: Placebo
    Capsules matched to study drug minus active substance.

Recruiting Locations

The University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Marisa Fernandez
210-450-8016
fernandezm10@uthscsa.edu

More Details

Status
Recruiting
Sponsor
Mirum Pharmaceuticals, Inc.

Study Contact

Clinical Trials Mirum
+16506674085
clinicaltrials@mirumpharma.com

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.