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Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

NCT04382404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-01-01

Study results available
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Summary

A single-arm, single-center, open label Phase 1 study of a 12-week course of Sofosbuvir (SOF)/Velpatasvir (VEL) in 10 HCV-infected pregnant women 1 that will evaluate the plasma pharmacokinetic parameters of SOF/VEL administered during pregnancy and compare them to those of a historical cohort of nonpregnant women.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Sofosbuvir-Velpatasvir Drug Combination

One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Catherine Anne Chappell

    lead OTHER

Principal Investigators

  • Catherine Chappell, MD, MSc · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-22
Primary Completion
2023-10-16
Completion
2023-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04382404 on ClinicalTrials.gov