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Anti-viral

Sofosbuvir-Velpatasvir for Chronic Hepatitis C During Pregnancy

Phase 1
Waitlist Available
Led By Catherine Chappell, MD, MSc
Research Sponsored by Catherine Chappell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Singleton gestation with no known fetal abnormalities
Singleton gestation with no known fetal abnormalities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 months
Awards & highlights

Study Summary

This trial will study the effects of a 12-week course of the drugs Sofosbuvir and Velpatasvir on HCV-infected pregnant women, and compare the results to a historical cohort of nonpregnant women.

Eligible Conditions
  • Chronic Hepatitis C

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are pregnant with only one baby and there are no known problems with the baby's health.
Select...
You are pregnant with one baby and there are no known health issues with the baby.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration Versus Time Curve of GS-331007
Area Under the Plasma Concentration Versus Time Curve of Sofosbuvir
Area Under the Plasma Concentration Versus Time Curve of Velpatasvir
+3 more
Secondary outcome measures
-Weight of Infant Participant
Frequency of Delivery Modes
Gestational Age at Delivery
+13 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sofosbuvir-VelpatasvirExperimental Treatment1 Intervention
Sofosbuvir-Velpatasvir
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Velpatasvir
FDA approved

Find a Location

Who is running the clinical trial?

Catherine ChappellLead Sponsor
3 Previous Clinical Trials
181 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,952 Previous Clinical Trials
2,660,833 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,077 Previous Clinical Trials
836,939 Total Patients Enrolled

Media Library

Sofosbuvir-Velpatasvir Drug Combination (Anti-viral) Clinical Trial Eligibility Overview. Trial Name: NCT04382404 — Phase 1
Chronic Hepatitis C Research Study Groups: Sofosbuvir-Velpatasvir
Chronic Hepatitis C Clinical Trial 2023: Sofosbuvir-Velpatasvir Drug Combination Highlights & Side Effects. Trial Name: NCT04382404 — Phase 1
Sofosbuvir-Velpatasvir Drug Combination (Anti-viral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04382404 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of participants enrolled in this clinical trial?

"Currently, no new candidates are being recruited for this trial. The initial posting was dated October 22nd 2020 and the most recent update happened on September 8th 2022. In case you are interested in another study, there are 280 trials searching for individuals with hepatitis c and 27 studies that involve Sofosbuvir-Velpatasvir Drug Combination presently recruiting patients."

Answered by AI

Is the Sofosbuvir-Velpatasvir Drug Combination a viable option for treatment with limited deleterious effects?

"As it is currently in its initial testing stage, the Sofosbuvir-Velpatasvir Drug Combination has a safety rating of 1 due to limited evidence supporting both efficacy and security."

Answered by AI

Could I be a potential candidate for this experiment?

"This trial is accepting a maximum of 10 applicants who are aged between 18 and 39 years old, have chronic hepatitis c, and meet the other inclusion criteria."

Answered by AI

What aim is this experiment striving to accomplish?

"According to information provided by the study sponsor, Gilead Sciences, the primary outcome that will be observed over a 3-month period is Maximum Concentration of GS-331007 in Plasma. As for secondary outcomes, this trial shall consider Number of Infant Participants with Congenital Anomalies (determined via medical record review), Percentage of Unbound Velpatasvir out of total Velpatasvir present in plasma, and Quantity of Hepatitis c Virus identified in infant plasma at birth and 1-3 months, 6 months, and 12 months postpartum."

Answered by AI

Is the age range for this clinical trial inclusive of those under 35?

"The upper and lower age limit for potential participants in this medical trial are set at 18 and 39 years old respectively."

Answered by AI

Are enrolment applications being accepted at this time for the trial?

"This particular study is not recruiting participants at this time, as displayed on clinicaltrials.gov; the trial was originally posted in October 2020 and last modified in September 2022. Despite its closure, there are currently 307 other trials that remain open with active recruitment needs."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~2 spots leftby Mar 2025