Actively Recruiting
Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-24
30
Participants Needed
10
Research Sites
73 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Legal age or able to provide informed consent according to site policies
- Willing and able to provide written informed consent for self and infant participation
- Age between 16 and 45 years at entry
- Gestational age between 14 weeks and 32 weeks at entry
- No multiple pregnancy, fetal anomalies, or intrauterine growth restriction by ultrasound
- Detectable hepatitis C virus RNA within 30 days prior to entry
- Negative hepatitis B surface antigen test within 30 days prior to entry
- Liver enzyme (AST, ALT) levels less than 10 times the upper limit of normal within 30 days prior to entry
- Hemoglobin of at least 8.5 g/dL and creatinine less than 1.8 times upper limit of normal within 30 days prior to entry
- Normal or mild abnormal results for INR, platelet count (at least 100,000 cells/mm3), and total bilirubin within 30 days prior to entry
- HIV status determined per protocol requirements
- If living with HIV, must have suppressed viral load on specific antiretroviral regimen for at least 30 days prior to entry
- Plans to remain near study site during pregnancy and for 10 weeks postpartum or 20 weeks post-entry
You will not qualify if you...
- Previous treatment for hepatitis C including direct-acting antivirals or interferon
- High risk for preterm delivery due to past spontaneous delivery before 34 weeks or shortened cervix less than 20 mm in current pregnancy
- Use of prohibited medications within 14 days prior to entry
- Acute hepatitis unrelated to hepatitis C with elevated liver enzymes (AST or ALT 2.5 times upper limit of normal or higher)
- Evidence or history of decompensated liver disease or related serious liver conditions
- Any other significant medical condition judged by the investigator to make participation unsafe or interfere with study results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
USC LA
Los Angeles, California, United States, 90089
Actively Recruiting
2
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Not Yet Recruiting
3
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Univ. of Florida Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
5
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60614
Actively Recruiting
6
Johns Hopkins University Baltimore
Baltimore, Maryland, United States, 21287
Actively Recruiting
7
SUNY Stony Brook
Stony Brook, New York, United States, 11794
Actively Recruiting
8
Bronx-Lebanon Hospital Center
The Bronx, New York, United States, 10457
Actively Recruiting
9
Jacobi Medical Center
The Bronx, New York, United States, 10461
Not Yet Recruiting
10
Baylor College of Medicine//Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
I
IMPAACT ClinicalTrials.gov Coordinator
CONTACT
K
Katie McCarthy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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