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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 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.

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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.

Conditions Studied

Hepatitis C, Chronic Pregnancy; Infection

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

FieldValue
Enrollment Target 100 participants
Start Date 2022-04-04
Est. Completion 2026-06
Phase Phase 4

Sponsor

Catherine Anne Chappell

2 total trials

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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, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 372-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (73% lower). The listed sponsor is Catherine Anne Chappell, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 9 study locations spanning 6 distinct geographic areas - top geographies include 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.

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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.