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NCT07040319 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target

NCT07040319 is a Phase 1 study that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants.

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The verdict

NCT07040319, a Phase 1 study, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study 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.

Interventions

  • DRUG Glecaprevir/pibrentasvir

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-06-25
Est. Completion 2027-10-30
Phase Phase 1

What the Registry Record Tells You About NCT07040319

The ClinicalTrials.gov registry entry for NCT07040319 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Glecaprevir/pibrentasvir is the first listed.

NCT07040319 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT07040319 about?

NCT07040319 is a clinical study titled "Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV". 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 inf...

What is the current status of trial NCT07040319?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-06-25. Estimated completion is 2027-10-30.

What interventions are being tested in trial NCT07040319?

The interventions under investigation include: Glecaprevir/pibrentasvir (DRUG).

Who is sponsoring clinical trial NCT07040319?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.