deltatrials
Recruiting INTERVENTIONAL NCT07040319

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

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

Sponsor: AbbVie

Conditions Hepatitis C
Updated 4 times since 2025 Last updated: Apr 21, 2026 Started: May 31, 2026 Primary completion: Oct 30, 2027 Completion: Oct 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Hepatitis C and is currently actively recruiting participants. AbbVie leads this study, which shows 4 recorded versions since 2026 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jul 2025 – ~Sep 2025 · 2 months · monthly snapshotNot Yet Recruiting~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshotNot Yet Recruiting~Feb 2026 – ~Apr 2026 · 3 months · monthly snapshotNot Yet RecruitingApr 28, 2026 – present · 2 months · daily APIRecruiting

Change History

4 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Recruiting

    Status: Not Yet RecruitingRecruiting · Phase: PHASE1/PHASE2None

  2. Feb 2026 — Apr 2026 [monthly]

    Not Yet Recruiting PHASE1/PHASE2

  3. Sep 2025 — Feb 2026 [monthly]

    Not Yet Recruiting PHASE1/PHASE2

  4. Jul 2025 — Sep 2025 [monthly]

    Not Yet Recruiting PHASE1/PHASE2

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • AbbVie
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .