NCT07040319 · National Institute of Allergy and Infectious Diseases (NIAID)
Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
What this study is about
This is a Phase I/II, multi-site, where both patients and doctors know the treatment given, single treatment group$1 study to describe the how the drug moves through the body (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.
View original scientific description
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.
Interventions
DRUG
Glecaprevir/pibrentasvir
100 mg glecaprevir and 40 mg pibrentasvir for a total daily dose of glecaprevir 300 mg/pibrentasvir 120 mg
Primary outcome measures
Geometric mean AUC0-24h
Time frame: At weeks 3 & 6
Area under the curve from start of dose to 24 hours post dose
Geometric mean Cmax
Time frame: At weeks 3 & 6
Peak concentration from start of dose to 24 hours post dose
Geometric mean C24h
Time frame: At weeks 3 & 6
Concentration at 24 hours post dose
Percentage of pregnant/ postpartum participants who experience a grade 3 or higher adverse event assessed as related to study drug
Time frame: Initiation of treatment to a) completion of treatment and b) latter of 10 weeks post-partum or 20 weeks post treatment initiation
Percentage of pregnant participants who experience a serious adverse event assessed as related to study drug
Time frame: Initiation of treatment to a) completion of treatment and b) latter of 10 weeks post-partum or 20 weeks post treatment initiation
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with institutional review board/ethics committee (IRB/EC) policies and procedures
- Willing and able to provide written informed consent for their own and their infant's study participation
- At entry, 16-45 years of age (inclusive)
- At entry, gestational age of 14-32 weeks, defined as greater than 13 weeks plus six days and less than or equal to 32 completed weeks gestation, as determined by the site investigator based on best obstetric estimate
- At screening and at study entry, no evidence of multiple gestation, fetal anomalies, or intrauterine fetal growth restriction, as determined by the site investigator based on ultrasound
- At screening, detectable HCV RNA test result based on testing of a specimen collected within 30 days prior to entry
- At screening, negative test results for hepatitis B surface antigen based
Where
- Los Angeles, California
- Aurora, Colorado
- Jacksonville, Florida
- Chicago, Illinois
- Baltimore, Maryland
- Stony Brook, New York
- The Bronx, New York
- Houston, Texas
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), AbbVie
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 14, 2026 · Source of record for eligibility and locations