A pharmacokinetic (PK) study of directly acting antiviral therapy for hepatitis C in pregnancy

  • Giles, Michelle (Primary Chief Investigator (PCI))
  • Sasadeusz, Joe John (Chief Investigator (CI))
  • Kiser, Jennifer (Chief Investigator (CI))
  • Hodges, Ryan (Chief Investigator (CI))
  • Said, Joanne M (Chief Investigator (CI))

Project: Research

Project Details

Project Description

NMA HREC Reference Number: HREC/47223/MonH-2018-157009(v1)
NMA SSA Reference Number: SSA/47223/MonH-2019-167633(v3)
Monash Health Ref: RES-18-0000-697A


The aim of the study is to recruit 10 pregnant women and undertake an open-label evaluation of the pharmacokinetics (PK) and safety of treating HCV-infected pregnant women with a 12 week course of Sofosbuvir and Velpatasvir SOF/VEL. This study is primarily to analyse PK and safety. Although endpoints such as maternal cure and perinatal transmission will be included, these are not the primary endpoints and the study is therefore not powered to analyse these.
Short titleHCV & Pregnancy Study
StatusActive
Effective start/end date2/08/191/08/24

Keywords

  • Clinical trial
  • treatment efficacy
  • Hepatitis C
  • pregnancy
  • pharmacokinetics