RecruitingPhase 1Phase 2NCT07040319

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

30 participants

Start Date

Jun 30, 2026

Study Type

INTERVENTIONAL

Conditions

Hepatitis C

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.

Eligibility

Sex: FEMALEMin Age: 16 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Glecaprevir/pibrentasvir for people with hepatitis c. The study is currently recruiting participants at 10 locations. People eligible for this study include women aged 16 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlecaprevir/pibrentasvir

100 mg glecaprevir and 40 mg pibrentasvir for a total daily dose of glecaprevir 300 mg/pibrentasvir 120 mg

Locations(10)

USC LA

Los Angeles, California, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Univ. of Florida Jacksonville

Jacksonville, Florida, United States

Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Johns Hopkins University Baltimore

Baltimore, Maryland, United States

SUNY Stony Brook

Stony Brook, New York, United States

Bronx-Lebanon Hospital Center

The Bronx, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

Baylor College of Medicine//Texas Children's Hospital

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07040319

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