CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 11 enrolled
Drug / intervention
Sofosbuvir-Velpatasvir Drug Combinationdrug
Likely dose
Sofosbuvir-Velpatasvir Drug Combination 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04382404
NCT04382404Phase 1Completed
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Phase 1 Pharmacokinetic Trial of Sofosbuvir/Velpatasvir in Pregnant Women With Chronic Hepatitis C Virus Infection

Catherine Anne Chappell·interventional·Posted May 11, 2020·Updated Jan 1, 2025

In Brief

A Phase 1 clinical trial evaluating Sofosbuvir-Velpatasvir Drug Combination for Hepatitis C, Chronic. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesUnited States
CollaboratorsGilead Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedMay 11, 2020
Enrollment StartOct 22, 2020
Primary CompletionOct 16, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.1 years ago

Interventions

Sofosbuvir-Velpatasvir Drug Combinationdrug

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