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

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ClinicalTrials.gov Identifier: NCT04718961
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Mirum Pharmaceuticals, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Intrahepatic Cholestasis of Pregnancy Drug: Volixibat Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a/2b Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in Adult Women With Intrahepatic Cholestasis of Pregnancy and Elevated Serum Bile Acid Concentrations (OHANA).
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024


Arm Intervention/treatment
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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Mean change in serum bile acids [ Time Frame: Through to end of treatment, up to 21 weeks ]

Secondary Outcome Measures :
  1. Mean change in the weekly average worst daily itch score as measured by the Adult Itch Reported Outcome (ItchRO) [ Time Frame: Through to end of treatment, up to 21 weeks ]
    The Adult ItchRO is an 11-point NRS measurement of itch severity ranging from 0=no itch to 10=worst possible itch.

  2. Proportion of participants experiencing one or more of adverse perinatal outcomes [ Time Frame: Through to end of treatment, up to 21 weeks ]
  3. The incidence of adverse events [ Time Frame: Through to study completion, up to 25 weeks ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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 clinical study at screening or planning to participate in another contemporaneous clinical study while participating in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04718961


Contacts
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Contact: Clinical Trials Mirum +16506674085 clinicaltrials@mirumpharma.com
Contact: Medinfo Mirum medinfo@mirumpharma.com

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Stacy Harris    205-996-6262    stacylharris@uabmc.edu   
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06511
Contact: Lauren Parley    203-500-3995    lauren.perley@yale.edu   
United States, Texas
The University of Texas Medical Branch - Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Liz Welch    409-747-6622    elwelch@UTMB.EDU   
Contact: Ashley Salazar    409-772-0312    assalaza@utmb.edu   
University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77030
Contact: Connor Yee    713-500-6398    Connor.Yee@uth.tmc.edu   
United Kingdom
Medway NHS Foundation Trust Recruiting
Gillingham, Kent, United Kingdom, ME7 5NY
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
St Thomas' Hospital Recruiting
London, United Kingdom, SE 1 7EH
Sponsors and Collaborators
Mirum Pharmaceuticals, Inc.
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Responsible Party: Mirum Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04718961    
Other Study ID Numbers: VLX-401
2020-003448-96 ( EudraCT Number )
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mirum Pharmaceuticals, Inc.:
Pruritus
Itch
Itching
Cholestasis
Bile Acid
Pregnancy
Pregnant
Intrahepatic
Liver
ICP
Additional relevant MeSH terms:
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Cholestasis
Cholestasis, Intrahepatic
Pregnancy Complications
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Volixibat
Lipid Regulating Agents