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NCT04382404 · ClinicalTrials.gov registry record · Phase 1
Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir
A Phase 1 study, sponsored by Catherine Anne Chappell.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT04382404: Completed Phase 1 study, sponsored by Catherine Anne Chappell.
NCT04382404 is a Phase 1 study that has completed, run by Catherine Anne Chappell. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04382404, a Phase 1 study, has completed, sponsored by Catherine Anne Chappell.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
A single-arm, single-center, open label Phase 1 study of a 12-week course of Sofosbuvir (SOF)/Velpatasvir (VEL) in 10 HCV-infected pregnant women 1 that will evaluate the plasma pharmacokinetic parameters of SOF/VEL administered during pregnancy and compare them to those of a historical cohort of nonpregnant women.
Primary Outcome
Maximum concentration of Velpatasvir measured in maternal plasma samples. Plasma samples were obtained pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 5-, 8-, and 12- and 24 hours post-dose at the 3- and 9-week visits after treatment initiation. At the 6-week visit, a single convenience blood sample was collected.
Interventions
- DRUG Sofosbuvir-Velpatasvir Drug Combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-10-22 |
| Est. Completion | 2023-10-16 |
| Phase | Phase 1 |
What the finished NCT04382404 record still lists
NCT04382404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Sofosbuvir-Velpatasvir Drug Combination is the first listed.
NCT04382404 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04382404 about?
NCT04382404 is a clinical study titled "Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir". A single-arm, single-center, open label Phase 1 study of a 12-week course of Sofosbuvir (SOF)/Velpatasvir (VEL) in 10 HCV-infected pregnant women 1 that will evaluate the plasma pharmacokinetic parameters of SOF/VEL administered during pregnancy and compare them to those of a historical cohort of no...
What is the current status of trial NCT04382404?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2020-10-22. Estimated completion is 2023-10-16.
What interventions are being tested in trial NCT04382404?
The interventions under investigation include: Sofosbuvir-Velpatasvir Drug Combination (DRUG).
Who is sponsoring clinical trial NCT04382404?
This trial is sponsored by Catherine Anne Chappell, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04382404's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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