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Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
NCT05140941 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05140941
The ClinicalTrials.gov registry entry for NCT05140941 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Catherine Anne Chappell, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05140941 reports 9 study locations spanning 6 distinct geographic areas — top geographies include Ontario, Ohio, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05140941?
The interventions under investigation include: Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05140941?
This trial is sponsored by Catherine Anne Chappell, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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