drugset / Trial / NCT07040319
Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
Phase 1/2
Recruiting
30 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
AbbVie · collabEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Institute of Mental Health (NIMH) · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-06-25
- Primary completion
- 2027-10-30
- Completion
- 2027-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | glecaprevir | Other / unclassified | 300 mg | Oral |
| Subject | pibrentasvir | Other / unclassified | 120 mg | Oral |