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Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet for Chronic Hepatitis C

The Ohio State University Wexner Medical Center, Columbus, OH
Chronic Hepatitis C+1 More ConditionsSofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet - Drug
Eligibility
18 - 45
Female

Study 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.

Eligible Conditions
  • Pregnancy Infection
  • Chronic Hepatitis C

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

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Epclusa
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Study Objectives

2 Primary · 31 Secondary · Reporting Duration: Approximately 12 months

Approximately 12 months
Head circumference of infant participant at 12 months
Length of infant participant at 12 months
Number of Infant Participants with Any Neurological Development Score Less than 6 at 12 months
Number of infant participants with with plasma level of HCV RNA PCR viral load that is below the lower limit of quantification at 12 months
Weight of infant participant at 12 months
Approximately 12 weeks
Number of maternal participants with sustained virologic response after completion of SOF/VEL treatment (SVR12)
Approximately 28 weeks
Number of maternal deaths
Number of maternal participants that are admitted to the intensive care unit
Number of maternal participants that deliver prior to 37 weeks' gestation
Number of maternal participants that develop gestational diabetes
Number of maternal participants that develop severe maternal morbidity
Number of maternal participants that experience a hypertensive disorder of pregnancy
Number of maternal participants that experience cholestasis of pregnancy
Number of maternal participants that experience intrapartum hemorrhage
Number of maternal participants that experience intrauterine growth restriction
Number of maternal participants that experience postpartum hemorrhage
Number of maternal participants whose pregnancy results in a stillbirth or intrauterine fetal demise
Approximately 4 weeks
Number of neonatal deaths
Number of neonates admitted to the neonatal intensive care unit
Number of neonates with major malformations
Number of preterm neonates (<37 weeks) admitted to the neonatal intensive care unit for severe neonatal morbidity
Number of term neonates (>=37 weeks) admitted to the neonatal intensive care unit for severe neonatal morbidity
Approximately 6 months
Head circumference of infant participant at 6 months
Length of infant participant at 6 months
Number of Infant Participants with Any Neurological Development Score Less than 6 at 6 months
Number of infant participants with with plasma level of HCV RNA PCR viral load that is below the lower limit of quantification at 6 months
Weight of infant participant at 6 months
Approximately 8 weeks
Head circumference of infant participant at 8 weeks
Length of infant participant at 8 weeks
Number of infant participants with with plasma level of HCV RNA PCR viral load that is below the lower limit of quantification at 8 weeks
Weight of infant participant at 8 Weeks
Approximately six months
Number of infants that experience an adverse event that is deemed related to Sofosbuvir/Velpatasvir
Number of maternal participants that experience an adverse event that is deemed related to Sofosbuvir/Velpatasvir

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Epclusa
3
Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet
3
Difelikefalin 1 mg Oral Tablet

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1 Treatment Group

Sofosbuvir/Velpatasvir
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet · No Placebo Group · Phase 4

Sofosbuvir/Velpatasvir
Drug
Experimental Group · 1 Intervention: Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 12 months

Who is running the clinical trial?

Catherine Anne ChappellLead Sponsor
2 Previous Clinical Trials
82 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,038 Previous Clinical Trials
776,217 Total Patients Enrolled
Catherine ChappellLead Sponsor
3 Previous Clinical Trials
91 Total Patients Enrolled
Catherine Chappell, MD, MScPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
10 Total Patients Enrolled

Eligibility Criteria

Age 18 - 45 · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your baby does not have major physical problems that could affect delivery or newborn health based on a detailed scan. The Protocol Safety Review Team will make sure of this before you can join the trial.
References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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