Recruiting
Phase 1
Phase 2

GLE/PIB

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT07040319

Conditions

Hepatitis C

Eligibility Criteria

Sex: Female

Age: 16 - 45

Healthy Volunteers: Not accepted

Interventions

Glecaprevir/pibrentasvir

Study Details

Brief summary:

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

Hepatitis C

Study ID

NCT07040319

Start date

Jun 25, 2026

Status verified date

Aug, 2026

Completion date

Mar 3, 2028

Anticipated

Primary completion date

Mar 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 45

Healthy Volunteers: Not accepted

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 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 Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GLE/PIB

Pregnant participants will take three (3) GLE/PIB fixed-dose combination tablets orally once daily with food for eight weeks

Interventions

Glecaprevir/pibrentasvir

100 mg glecaprevir and 40 mg pibrentasvir for a total daily dose of glecaprevir 300 mg/pibrentasvir 120 mg

Primary outcome measure

  • Geometric mean AUC0-24h [ Time Frame: At weeks 3 & 6 ]
  • Geometric mean Cmax [ Time Frame: At weeks 3 & 6 ]
  • Geometric mean C24h [ Time Frame: At weeks 3 & 6 ]
  • 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 ]

Central Contacts and Locations

Central contacts

IMPAACT ClinicalTrials.gov Coordinator

impaact.ctgov@fstrf.org

Katie McCarthy

919-321-3326kmccarthy@fhi360.org

Locations

USC LA

Recruiting

Los Angeles, California, United States, 90089

Contacts

Yvonne Morales, LVN

323-865-1561ytr@usc.edu

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Carrie Chambers, RN

720-777-4424carrie.chambers@childrenscolorado.org

Univ. of Florida Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Adnan Shabbir

904-244-3796adnan.shabbir@jax.ufl.edu

Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60614

Contacts

Rasima Cehic, RN

312-227-8273rcehic@luriechildrens..org

Johns Hopkins University Baltimore

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Amanda Haines, BSN, RN

443-287-8888ahaines8@jhmi.edu

SUNY Stony Brook

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Barsha Chakraborty, MPH

631-444-8225barsha.chakraborty@stonybrookmedicine.edu

Bronx-Lebanon Hospital Center

Recruiting

The Bronx, New York, United States, 10457

Contacts

Martha Cavallo, PNP

718-960-1016mcavallo@bronxcare.org

Baylor College of Medicine//Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Mariam Pontifes

832-822-1268mepontif@texaschildrens.org

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • HIV
  • Hepatitis C
  • Pregnancy
  • Glecaprevir/Pibrentasvir

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-08-14.