A Placebo-controlled RCT Volixibat Intrahepatic Cholestasis Pregnancy

• Research type

  Research Study

• Full 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)

• IRAS ID

  287442

• Contact name

  Lara Longpre

• Contact email

  llongpre@mirumpharma.com

• Sponsor organisation

  Mirum Pharmaceutical Inc.

• Eudract number

  2020-003448-96

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT00000000

• Clinicaltrials.gov Identifier

  147904, IND Number

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  Intrahepatic cholestasis of pregnancy (ICP) is a potentially serious liver disorder that can develop in pregnancy. Normally, bile acids (fluids formed in liver) flow from the liver to the gut to help digest food. In ICP, the bile acids do not flow properly and build up in the body instead.

  The purpose of this study is to learn more about the use of the study medicine, volixibat, for the treatment of ICP. Approximately 290 people will be in this study from all over the world. Participants will be in this study until approximately 4 weeks after the birth of the baby.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  21/WM/0017

• Date of REC Opinion

  8 Mar 2021

• REC opinion

  Further Information Favourable Opinion