NCT07040319

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Female
• Age: 16 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Glecaprevir/pibrentasvir	100 mg glecaprevir and 40 mg pibrentasvir for a total daily dose of glecaprevir 300 mg/pibrentasvir 120 mg

Timeline

• Start date: 2026-02-28
• Primary completion: 2027-07-30
• Completion: 2027-07-30
• First posted: 2025-06-27
• Last updated: 2026-01-29

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study