Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir - Trial NCT04382404
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.
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Study Focus
Sponsor & Location
Catherine Chappell
University of Pittsburgh
Timeline & Enrollment
Phase 1
Oct 22, 2020
Dec 30, 2023
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
Data Source
ClinicalTrials.gov
NCT04382404
Non-Device Trial