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Sofosbuvir-Velpatasvir for Chronic Hepatitis C During Pregnancy
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.
- Chronic Hepatitis C
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You are pregnant with one baby and there are no known health issues with the baby.You are 23 weeks' to 25 weeks' pregnant at enrollment.You have a history of giving birth too early or have a shorter than normal cervix.You are pregnant with only one baby and there are no known problems with the baby's health.
- Group 1: Sofosbuvir-Velpatasvir
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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