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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: Recruiting Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area under the curve from start of dose to 24 hours post dose
Interventions
- DRUG Glecaprevir/pibrentasvir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-06-25 |
| Est. Completion | 2027-10-30 |
| Phase | Phase 1 |
What NCT07040319 shows while recruiting
NCT07040319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Glecaprevir/pibrentasvir is the first listed.
NCT07040319 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07040319's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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