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Completed Phase 1 Interventional Results available

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

ClinicalTrials.gov ID: NCT04382404

Public ClinicalTrials.gov record NCT04382404. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 11:28 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT04382404
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Catherine Anne Chappell
Other
Enrollment
11 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 39 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 22, 2020 (Actual)
Primary completion
Oct 16, 2023 (Actual)
Completion
Oct 16, 2023 (Actual)
Last update posted
Jan 1, 2025

2020 – 2023

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Pittsburgh, Magee Womens Hospital Pittsburgh Pennsylvania 15213 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04382404, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 1, 2025 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04382404 live on ClinicalTrials.gov.

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