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

NCT07040319 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IMPAACT 2041
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

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

Keywords

HIV; Hepatitis C; Pregnancy; Glecaprevir/Pibrentasvir

Outcome Measures

Primary Outcomes (5)

• Geometric mean AUC0-24h

  Area under the curve from start of dose to 24 hours post dose

  At weeks 3 & 6

• Geometric mean Cmax

  Peak concentration from start of dose to 24 hours post dose

  At weeks 3 & 6

• Geometric mean C24h

  Concentration at 24 hours post dose

  At weeks 3 & 6

• Percentage of pregnant/ postpartum participants who experience a grade 3 or higher adverse event assessed as related to study drug

  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

  Initiation of treatment to a) completion of treatment and b) latter of 10 weeks post-partum or 20 weeks post treatment initiation

Secondary Outcomes (16)

• Percentage of pregnant/postpartum participants with sustained virologic response (SVR12)

  12 weeks after planned treatment completion

• Percentage of pregnant participants with spontaneous abortions or miscarriage

  At birth/delivery

• Percentage of pregnant participants with stillbirths

  At birth/delivery

• Percentage of infants small for gestational age

  At birth/delivery

• Percentage of infants with low birth weight

  At birth/delivery

Study Arms (1)

GLE/PIB

EXPERIMENTAL

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

Drug: Glecaprevir/pibrentasvir

Interventions

Glecaprevir/pibrentasvir DRUG

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

Also known as: GLE/PIB

GLE/PIB

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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
• 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)

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
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Mental Health (NIMH): collaborator
• AbbVie: collaborator

Study Sites (10)

USC LA

Los Angeles, California, 90089, United States

Location

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Univ. of Florida Jacksonville

Jacksonville, Florida, 32209, United States

Location

Lurie Children's Hospital of Chicago

Chicago, Illinois, 60614, United States

Location

Johns Hopkins University Baltimore

Baltimore, Maryland, 21287, United States

Location

SUNY Stony Brook

Stony Brook, New York, 11794, United States

Location

Bronx-Lebanon Hospital Center

The Bronx, New York, 10457, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Baylor College of Medicine//Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

IMPAACT ClinicalTrials.gov Coordinator

CONTACT

impaact.ctgov@fstrf.org

Katie McCarthy

CONTACT

919-321-3326; kmccarthy@fhi360.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 27, 2025
• Study Start: February 28, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: January 29, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
• Access Criteria: * Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network. * For what types of analyses? * To achieve aims in the proposal approved by the IMPAACT Network. * By what mechanism will data be made available? * Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https:// www.impaactnetwork.org/ resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.

Locations

US (10)