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Antiviral

Hepatitis C Medication for Hepatitis C Organ Transplant

Phase 4
Waitlist Available
Led By Lindsey Baden, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-transplant
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial uses antiviral medications to treat or prevent Hepatitis C in adults waiting for heart, lung, or kidney transplants who receive organs from Hepatitis C positive donors. The medications work by stopping the virus from multiplying in the body. These antiviral agents have been shown to be highly effective in treating Hepatitis C infection.

Eligible Conditions
  • Hepatitis C
  • Awaiting Organ Transplant

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Graft survival
HCV status of the transplant recipient
Secondary study objectives
Treatment related adverse events

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: HCV NAT Positive DonorExperimental Treatment1 Intervention
Intervention: 2 week treatment course with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily Participants who receive allografts from a donor who is HCV NAT positive will receive treatment with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily, beginning on the day of transplant.
Group II: HCV NAT Negative, HCV Ab Positive DonorExperimental Treatment2 Interventions
Intervention: HCV viral load monitoring Participants who receive allografts from a donor who is HCV Ab positive and NAT negative will have close serial HCV viral load monitoring and will be treated with a direct acting antiviral, 400mg / velpatasvir 100mg daily, for 6 weeks if HCV viremia develops.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sofosbuvir/velpatasvir
2019
Completed Phase 4
~3800

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,843,318 Total Patients Enrolled
Lindsey Baden, MDPrincipal Investigator - Brigham and Women's Hospital
Brigham & Women's Hospital, Brigham and Women's Physicians Organization, Dana-Farber Cancer Institute
A Einstein College Of Medical Of Yeshiva University (Medical School)
Beth Israel Deaconess Medical Center (Residency)
7 Previous Clinical Trials
817 Total Patients Enrolled

Media Library

Sofosbuvir/velpatasvir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT03086044 — Phase 4
Hepatitis C Research Study Groups: HCV NAT Positive Donor, HCV NAT Negative, HCV Ab Positive Donor
Hepatitis C Clinical Trial 2023: Sofosbuvir/velpatasvir Highlights & Side Effects. Trial Name: NCT03086044 — Phase 4
Sofosbuvir/velpatasvir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03086044 — Phase 4
~17 spots leftby Dec 2025
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