Clinical Trial

Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV

Recruiting Phase 1/2
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Summary
This is a Phase I/II, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection (acute or chronic) with or without HIV and to evaluate safety for their infants through 10 weeks postpartum.
Protocol Amendment History 5 changes
notable Primary completion pushed: 2027-10-30 -> 2028-03-03 2026-08-15
minor Completion pushed: 2027-10-30 -> 2028-03-03 2026-08-15
critical Recruitment opened 2026-04-25
notable Primary completion pushed: 2027-07-30 -> 2027-10-30 2026-04-25
minor Completion pushed: 2027-07-30 -> 2027-10-30 2026-04-25
Trial Details
NCT Number NCT07040319
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), AbbVie
Conditions Hepatitis C
Enrollment 30 participants
Start Date 2026-06-25
Primary Completion 2028-03-03 (estimated)
Study Completion 2028-03-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-14