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NCT05140941 · ClinicalTrials.gov registry record · Phase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
A Phase 4 study of Hepatitis C, Chronic and Pregnancy; Infection, sponsored by Catherine Anne Chappell.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 9
- Study locations
NCT05140941: Recruiting Phase 4 study of Hepatitis C, Chronic and Pregnancy; Infection, sponsored by Catherine Anne Chappell.
NCT05140941 is a Phase 4 study of Hepatitis C, Chronic and Pregnancy; Infection that is actively recruiting participants, run by Catherine Anne Chappell. The registered enrollment target is 100 participants, below the 372-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (73% lower). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05140941, a Phase 4 study of Hepatitis C, Chronic and Pregnancy; Infection, is actively recruiting participants, sponsored by Catherine Anne Chappell.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is a multicenter, single arm study of Sofosbuvir/Velpatasvir (SOF/VEL) for treatment of chronic hepatitis C infection during pregnancy. Treatment will be initiated during the second or third trimester in approximately 100 pregnant people. Maternal participants will take one SOF/VEL tablet once daily for 12 weeks (84 days) and followed until 12 weeks after treatment completion (postpartum). Infants will be followed from birth until one year of age. The primary objectives are to evaluate the sustained virologic response 12 weeks after completion of SOF/VEL treatment (SVR12) in participants treated during pregnancy and to evaluate impact of antenatal treatment with SOF/VEL on the gestational age at delivery.
Primary Outcome
Number of maternal participants with plasma level of HCV RNA PCR that is below the lower limit of quantification after completion of SOF/VEL treatment
Conditions Studied
Interventions
- DRUG Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet
Study Locations (9)
Ontario
- Victoria Hospital, London Health Sciences Center - London
- University Health Toronto, St Michaels Hospital - Toronto
- Toronto General Hospital, University Health Network - Toronto
Ohio
- The Christ Hospital - Cincinnati
- The Ohio State University Wexner Medical Center - Columbus
Pennsylvania
- University of Pittsburgh, Magee Womens Hospital - Pittsburgh
Tennessee
- Vanderbilt University Medical Center - Nashville
Utah
- University of Utah - Salt Lake City
West Virginia
- Marshall University - Huntington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-04-04 |
| Est. Completion | 2026-06 |
| Phase | Phase 4 |
What NCT05140941 shows while recruiting
NCT05140941 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 372-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 1 intervention - of which Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet is the first listed.
NCT05140941 lists 9 locations in 6 states (Ontario, Ohio, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT05140941 about?
NCT05140941 is a clinical study titled "Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy". This is a multicenter, single arm study of Sofosbuvir/Velpatasvir (SOF/VEL) for treatment of chronic hepatitis C infection during pregnancy. Treatment will be initiated during the second or third trimester in approximately 100 pregnant people. Maternal participants will take one SOF/VEL tablet once ...
What is the current status of trial NCT05140941?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2022-04-04. Estimated completion is 2026-06.
What conditions does trial NCT05140941 study?
This clinical trial studies the following conditions: Hepatitis C, Chronic, Pregnancy; Infection.
What interventions are being tested in trial NCT05140941?
The interventions under investigation include: Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT05140941?
This trial is sponsored by Catherine Anne Chappell, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05140941 being conducted?
This trial has 9 study locations across Ohio, Pennsylvania, Tennessee, Utah, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis C, Chronic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05140941's enrollment target sits among peer trials
100 16th of 26 higher than 10 of 26 other Hepatitis C, Chronic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C, Chronic 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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