Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study

Phase 1

• Conditions: Intrahepatic Cholestasis of Pregnancy (ICP) is an serious liver condition in pregnancy. The main symptom of this is itching. Ursodeoxycholic acid is routinely used to treat cholestasis but is not effective in reducing itch in all people who take it. Rifampcin has been used to reduce itch in people with Primary Biliary Cholangitis. This study will randomly allocate women with severe early onset ICP to receive either Ursodeoxycholic Acid, or the Investigational drug Rifampicin.; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-004011-44-FI
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-26
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 108

Inclusion Criteria

Women will be considered eligible for inclusion into the trial with the following criteria:
•Severe ICP (defined as pruritus with raised total serum BA =40 µmol/L) confirmed (see note below on standardisation of bile acid assays)
•Viable pregnancy between 14+0 and 33+6 weeks gestation inclusive (see note below on gestational age)
•No known lethal fetal anomaly
•Singleton pregnancy
•Obstetric care in a consultant-led unit
•Aged 18 years or over
•Written informed consent has been obtained

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

A potential participant who meets any of the following criteria will be excluded from participation in this study:
•A decision has already been made for delivery within the next 48 hours
•There is allergy to any component of the UDCA or RIF tablets
•The woman is taking other medication that has a significant interaction with rifampicin treatment
•There is a multi-fetal gestation
•There is laboratory-confirmed active hepatitis A or hepatitis B, or positive serology for hepatitis C
•There is current pre-eclampsia (ISSHP criteria)
•There is a known primary hepatic disorder, including a-1-antitrypsin deficiency and autoimmune hepatitis, including primary biliary cholangitis
•The woman is on current medication causing deranged liver enzymes
•The woman is unwilling for her baby to have standard Vitamin K administration at birth
•The woman has previously participated in TURRIFIC

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified