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

Brief Title

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

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).

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Mean change in serum bile acids

Secondary Outcome

 Mean change in the weekly average worst daily itch score as measured by the Adult Itch Reported Outcome (ItchRO)

Condition

Intrahepatic Cholestasis of Pregnancy

Intervention

Volixibat

Study Arms / Comparison Groups

 Volixibat 20mg
Description:  Participants randomized to this arm will receive volixibat 20mg twice daily.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

290

Start Date

January 4, 2021

Completion Date

January 2024

Primary Completion Date

January 2024

Eligibility 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.
      

Gender

Female

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

, +16506674085, [email protected]

Location Countries

New Zealand

Location Countries

New Zealand

Administrative Informations


NCT ID

NCT04718961

Organization ID

VLX-401

Secondary IDs

2020-003448-96

Responsible Party

Sponsor

Study Sponsor

Mirum Pharmaceuticals, Inc.


Study Sponsor

, , 


Verification Date

September 2021