Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV

NCT ID: NCT07040319

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-07-30

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GLE/PIB

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

Group Type: EXPERIMENTAL

Glecaprevir/pibrentasvir

Intervention Type: DRUG

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

Interventions

Glecaprevir/pibrentasvir

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

Intervention Type: DRUG

Other Intervention Names

GLE/PIB

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

AbbVie

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USC LA

Los Angeles, California, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Univ. of Florida Jacksonville

Jacksonville, Florida, United States

Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Johns Hopkins University Baltimore

Baltimore, Maryland, United States

SUNY Stony Brook

Stony Brook, New York, United States

Bronx-Lebanon Hospital Center

The Bronx, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

Baylor College of Medicine//Texas Children's Hospital

Houston, Texas, United States

Countries

United States

Central Contacts

IMPAACT ClinicalTrials.gov Coordinator

Role: CONTACT

impaact.ctgov@fstrf.org

Katie McCarthy

Role: CONTACT

kmccarthy@fhi360.org

919-321-3326

Facility Contacts

Yvonne Morales, LVN

Role: primary

ytr@usc.edu

323-865-1561

Misciel Macaraig, BA, CCRC

Role: primary

mbmacaraig@mednet.ucla.edu

310-206-6369

Carrie Chambers, RN

Role: primary

carrie.chambers@childrenscolorado.org

720-777-4424

Adnan Shabbir

Role: primary

adnan.shabbir@jax.ufl.edu

904-244-3796

Rasima Cehic, RN

Role: primary

rcehic@luriechildrens..org

312-227-8273

Amanda Haines, BSN, RN

Role: primary

ahaines8@jhmi.edu

443-287-8888

Barsha Chakraborty, MPH

Role: primary

barsha.chakraborty@stonybrookmedicine.edu

631-444-8225

Martha Cavallo, PNP

Role: primary

mcavallo@bronxcare.org

718-960-1016

Marlene Burey, RN, PNP

Role: primary

marlene.burey@nychhc.org

718-918-4783

Mariam Pontifes

Role: primary

mepontif@texaschildrens.org

832-822-1268

Other Identifiers

IMPAACT 2041

Identifier Type: -

Identifier Source: org_study_id