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NCT04382404

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

Phase 1 Pharmacokinetic Trial of Sofosbuvir/Velpatasvir in Pregnant Women With Chronic Hepatitis C Virus Infection
Catherine Chappell·Phase 1·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Hepatitis C, Chronic
Drug/Device/Intervention
Sofosbuvir-Velpatasvir Drug Combination
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Catherine Chappell
Funder
University of Pittsburgh
Location
Pittsburgh, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Oct 22, 2020
End date
Dec 30, 2023
Enrollment
10 participants
Primary outcome

Maximum Concentration of Velpatasvir in Plasma,Maximum Concentration of Sofosbuvir in Plasma,Maximum Concentration of GS-331007 in Plasma,Area Under the Plasma Concentration Versus Time Curve of Velpatasvir,Area Under the Plasma Concentration Versus Time Curve of Sofosbuvir,Area Under the Plasma Concentration Versus Time Curve of GS-331007

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.

ICD-10 classifications
Chronic viral hepatitis CAcute hepatitis CChronic hepatitis, unspecifiedChronic viral hepatitisChronic viral hepatitis, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04382404
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04382404 through Pure Global AI's free database. This Phase 1 trial is sponsored by Catherine Chappell and is currently Recruiting. The study focuses on Hepatitis C, Chronic. Target enrollment is 10 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.