TURRIFIC Protocol Version 8

• Research type

  Research Study

• Full title

  A randomised trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study, comparing their effectiveness in the reduction of pruritus.

• IRAS ID

  272398

• Contact name

  Jim Thornton

• Contact email

  Jim.Thornton@nottingham.ac.uk

• Sponsor organisation

  The University Of Adelaide

• Eudract number

  2018-004011-44

• Clinicaltrials.gov Identifier

  ACTRN12618000332224, ANZCTR

• Duration of Study in the UK

  2 years, 4 months, 15 days

• Research summary

  Intrahepatic Cholestasis of Pregnancy (ICP) is a serious liver condition in pregnancy. The main symptom of this condition is itching. Ursodeoxycholic acid is routinely used to treat cholestasis but is not effective in reducing itch in all people who take it. Rifampicin 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.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  20/SC/0237

• Date of REC Opinion

  10 Aug 2020

• REC opinion

  Further Information Favourable Opinion