NCT04718961Phase 2Terminated

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

Study sponsor: Mirum Pharmaceuticals, Inc. · MIRM

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2022-12-07Actual

Enrollment · participants4Actual

Source updated2024-08-06Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Intrahepatic Cholestasis of Pregnancy

Treatments or interventions studied

VolixibatDrugAlso known as SHP626
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Assess the Safety and Tolerability of Volixibat in Participants With ICP; description: To assess the safety and tolerability of volixibat in participants with ICP on the basis of the following endpoints: Proportion of participants experiencing one or more of the following: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), events of clinical interest (ECIs), and adverse events (AEs) that lead to discontinuation of study drugs. Clinically significant laboratory abnormalities; timeFrame: Through to end of treatment, up to 21 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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