RecruitingHepatitis C
Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
Eligible age
16–45 yrs
Accepts
Women
Locations
7 states
Healthy volunteers
No
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About this study
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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT07040319 · last updated 2026-07-01