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Antiviral

Hepatitis C Medication for Hepatitis C Organ Transplant

Phase 4
Recruiting
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

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

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
1,653 Previous Clinical Trials
11,490,887 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 Sep 2025
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