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IMPAACT 2041
Phase I/II Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women with Hepatitis C with and without HIV
Primary Protocol Team Members
Summary
IMPAACT 2041 is a Phase I/II Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir in Women with Hepatitis C During Pregnancy. The study is designed to evaluate the pharmacokinetics and safety of GLE/PIB during pregnancy and postpartum, and will follow pregnant women and their infants through three months postpartum. Site selection was completed in July 2023 and was opened to IMPAACT sites located in the United States only. Only US sites were invited to participate due to the expected availability of GLE/PIB.
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