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RECRUITING
NCT05140941
PHASE4

Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy

Sponsor: Catherine Anne Chappell

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2022-04-04

Completion Date

2026-06

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

Sofosbuvir/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