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.
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 title | HCV & Pregnancy Study |
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Status | Finished |
Effective start/end date | 2/08/19 → 1/08/24 |
Keywords
- Clinical trial
- treatment efficacy
- Hepatitis C
- pregnancy
- pharmacokinetics