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Recruiting Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT07040319

Public ClinicalTrials.gov record NCT07040319. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:48 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07040319
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
30 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
16 Years to 45 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 24, 2026
Primary completion
Mar 2, 2028
Completion
Mar 2, 2028
Last update posted
Aug 13, 2026

2026 – 2028

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
USC LA Los Angeles California 90089 Recruiting
David Geffen School of Medicine at UCLA Los Angeles California 90095 Not yet recruiting
University of Colorado Denver Aurora Colorado 80045 Recruiting
Univ. of Florida Jacksonville Jacksonville Florida 32209 Recruiting
Lurie Children's Hospital of Chicago Chicago Illinois 60614 Recruiting
Johns Hopkins University Baltimore Baltimore Maryland 21287 Recruiting
SUNY Stony Brook Stony Brook New York 11794 Recruiting
Bronx-Lebanon Hospital Center The Bronx New York 10457 Recruiting
Jacobi Medical Center The Bronx New York 10461 Not yet recruiting
Baylor College of Medicine//Texas Children's Hospital Houston Texas 77030 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07040319, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 13, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07040319 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →