RecruitingPhase 4NCT05140941

Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy

Safety, Tolerability, and Outcomes of Velpatasvir/SofosbuviR in Treatment of Chronic Hepatitis C Virus During Pregnancy (STORC)

Sponsor

Catherine Anne Chappell

Enrollment

100 participants

Start Date

Apr 4, 2022

Study Type

INTERVENTIONAL

Conditions

Hepatitis C, Chronic Pregnancy; Infection

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and effectiveness of treating chronic hepatitis C virus (HCV) infection during pregnancy using sofosbuvir/velpatasvir, a well-established oral antiviral medication, to reduce the risk of passing HCV to the baby. **You may be eligible if...** - You are between 18 and 45 years old - You have confirmed chronic hepatitis C (HCV antibody positive with detectable virus in blood, for at least 6 months) - You are pregnant or planning to become pregnant - You can provide consent and attend study visits **You may NOT be eligible if...** - You have acute (new) HCV infection (less than 6 months) - You cannot provide adequate contact information - You are unwilling or unable to follow study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet

One Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet taken once daily for 84 days.

Locations(9)

The Christ Hospital

Cincinnati, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

University of Pittsburgh, Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Utah

Salt Lake City, Utah, United States

Marshall University

Huntington, West Virginia, United States

Victoria Hospital, London Health Sciences Center

London, Ontario, Canada

University Health Toronto, St Michaels Hospital

Toronto, Ontario, Canada

Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT05140941

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