A Study Evaluating Treatment for Intrahepatic Cholestasis of Pregnancy (ICP) - A liver disorder that can develop in pregnancy

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)
Purpose

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment intrahepatic cholestasis of pregnancy (ICP).

Depending upon how many weeks pregnant you are when you are screened at the first study visit, study participation could last up to 27 weeks

Could this study be right for you?

Inclusion Criteria:
• Females aged 18 to 45 years old
• Viable pregnancy of 20 weeks 0 days above
• Diagnosis of intrahepatic cholestasis of pregnancy (ICP)
• Willing and able to not use of any of the following for the duration of the study: statins, rifampin, bile acid sequestrants (e.g., cholestyramine), peroxisome proliferator-activated receptor (PPAR) agonists/fibrate drugs (e.g., fenofibrate, bezafibrate), S-adenosyl methionine.

Exclusion Criteria:
• Presence of triplets or higher multiple gestation
• Breastfeeding
• Alcohol use disorder or substance abuse within 12 months
• Known diagnosis of HIV infection or HIV antibody positivity

Exclusion Criteria varies, please contact Study Coordinator for more information.

Age Range
18 and up