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Sofosbuvir/Velpatasvir for Hepatitis C in Pregnancy (STORC Trial)
STORC Trial Summary
This trial will study the effects of a new hepatitis C medication during pregnancy. Pregnant people will take the medication for 12 weeks, and their infants will be followed for a year after birth. The primary objectives are to see if the treatment is effective and if it has any impact on the gestational age at delivery.
STORC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTORC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.STORC Trial Design
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Who is running the clinical trial?
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- I have HIV, am on antiretroviral therapy, and my latest viral load was under 50 copies/mL.I don't have any major uncontrolled health issues apart from HCV or HIV.I was treated for hepatitis C but don't have proof of being virus-free after 12 weeks.I plan to stay near the study site for the next 16 months and can attend all visits.I have a documented history of cirrhosis.I have hepatitis C with a detectable virus level.I do not use recreational drugs, as confirmed by the study's lead doctor.I can stop or follow special instructions for my acid-suppressant meds during the study.I have had Hepatitis C for at least 6 months without severe liver symptoms.I am not taking any medications that can't be used with EPCLUSA®.I am between 18 and 45 years old.My unborn baby has a confirmed genetic abnormality.
- Group 1: Sofosbuvir/Velpatasvir
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Are there serious risks associated with taking Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet?
"There is ample evidence confirming the safety of Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet, thus it achieved a score of 3. This medication has been through Phase 4 trials and approved for general use."
Does this experiment encompass any geriatric participants?
"This clinical trial has stipulated that only individuals aged 18 to 45 can participate. For minors, there are 29 other trials available and for senior citizens 259 different studies have been posted."
Is enrollment currently open for this research study?
"Affirmative. The information stored on clinicaltrials.gov confirms that this investigation, which was initially posted on the 4th of April 2022, is actively recruiting volunteers. Up to 100 participants will be sought from a single medical facility."
What objectives are this clinical trial endeavoring to realize?
"The main outcome of this investigation, measured over a 28-week duration, is the number of pregnant women with sustained virological response after completing SOF/VEL treatment (SVR12). Secondary objectives include evaluating the plasma level of HCV RNA PCR viral load below quantifiable levels at 6 months for infants born to these mothers; measuring stillbirth or intrauterine demise in said mothers; and assessing intrapartum hemorrhage risk among participants."
What criteria must an individual meet to become a participant in this experiment?
"This clinical trial seeks to enroll 100 individuals aged 18-45 who have been diagnosed with chronic hepatitis c. Applicants must be able to provide an adequate amount of contact information, as well as a comprehensive anatomy scan that does not suggest any major structural abnormalities or anomalies which could affect delivery timing and neonatal outcomes according to the CDC's birth surveillance toolkit (https://www.cdc.gov/ncbddd/birthdefects/surveillancemanual/chapters/chapter-4/chapter4-1.html). This is determined by Protocol Safety Review Team prior to enrollment in the study."
How many participants have enrolled in the trial thus far?
"Affirmative. Data available on clinicaltrials.gov demonstrates that the research project, which was initially launched in April of 2022, is presently accepting participants. As many as 100 subjects are needed at one medical centre to complete this investigation."
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