Study of Glecaprevir/Pibrentasvir in Pregnant Women with Hepatitis C
This study is looking at the safety and how the body handles a medication called glecaprevir/pibrentasvir when it's started during pregnancy. This medication is for women who have hepatitis C (a liver infection), whether or not they also have HIV. Researchers will be measuring how much of the drug is in your body at certain times. They will also check the safety of the medication for you and your baby through 10 weeks after your baby is born. The study plans to enroll 30 women between 16 and 45 years old. The current recruitment status is unclear.
- Study design
- This is a Phase I/II, multi-site, open-label, single-arm study. It aims to enroll 30 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your baby's safety will be evaluated through 10 weeks postpartum (after birth).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07040319
Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
Recruiting
PHASE1Ages 16–45InterventionalTreatmentNational Institute of Allergy and Infectious Diseases (NIAID)Government-funded
~30 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Glecaprevir/pibrentasvir
At a glance
Recruiting sites
8 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Geometric mean AUC0-24h
Measured over At weeks 3 & 6
+4 more outcomes measured
Conditions
Where it's being run
10 sites across 7 statesNew York3
California2
Colorado1
Florida1
Illinois1
Maryland1
Texas1
Who to contact
IMPAACT ClinicalTrials.gov Coordinator
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 on testing of a specimen collected within 30 days prior to entry
At screening (i.e., from specimens collected within 30 days prior to entry), has normal, grade 1, grade 2, or grade 3 results for the following
Aspartate aminotransferase (AST) (\<10.0 x ULN)
Alanine aminotransferase (ALT) (\<10.0 x ULN)
At screening (i.e., from specimens collected within 30 days prior to entry), has normal, grade 1, or grade 2 results for the following
Hemoglobin (≥8.5 g/dL)
Creatinine (≤1.8 x ULN)
At screening (i.e., from specimens collected within 30 days prior to entry), has normal or grade 1 results for the following
International normalized ratio (INR) (\<1.5 x ULN)
Platelet count (≥100,000 cells/mm3)
Total bilirubin (\<1.6 x ULN)
HIV status determined based on testing meeting the requirements specified in protocol
For pregnant participants living with HIV: has a suppressed HIV viral load (HIV-1 RNA below the limit of quantification of the assay) on an ARV regimen for at least 30 consecutive days prior to entry that does not include efavirenz, etravirine, cobicistat, or any protease inhibitor (e.g., atazanavir, darunavir, lopinavir, ritonavir), as determined by the site investigator based on available medical records
At entry, expects to remain in the geographic area of the study site during pregnancy and for 10 weeks postpartum (or for 20 weeks post-entry, depending on gestational age at entry), as determined by the site investigator based on pregnant participant report
Exclusion
Any previous treatment for hepatitis C, including HCV DAAs or interferon-based treatment
High risk of preterm delivery, defined as either of the following:
History of spontaneous preterm delivery at less than 34 weeks, as determined by the site investigator based on pregnant participant report and available medical records, or
Shortened cervix less than 20 mm if noted on ultrasound during the current pregnancy, as determined by the site investigator based on available medical records
Receipt of any prohibited medication, within 14 days prior to entry, as determined by the site investigator based on pregnant participant report and available medical records
Any of the following liver-related conditions:
Clinical diagnosis of acute hepatitis not otherwise attributable to hepatitis C with AST or ALT ≥2.5 x ULN
Evidence of decompensated cirrhosis including history of or present variceal hemorrhage, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatocellular carcinoma, hepatorenal syndrome, or hepatopulmonary syndrome
Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
What this trial measures
- Geometric mean AUC0-24hAt weeks 3 & 6
Area under the curve from start of dose to 24 hours post dose
- Geometric mean CmaxAt weeks 3 & 6
Peak concentration from start of dose to 24 hours post dose
- Geometric mean C24hAt 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 drugInitiation 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 drugInitiation of treatment to a) completion of treatment and b) latter of 10 weeks post-partum or 20 weeks post treatment initiation