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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

Study Summary

This trial is testing a new way to treat hepatitis C in people who are waiting for a heart or lung transplant. The treatment is safe and effective so far.

Eligible Conditions

Hepatitis C
Awaiting Organ Transplant

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-transplant

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Graft survival

HCV status of the transplant recipient

Secondary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,612 Previous Clinical Trials

11,470,427 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently being admitted to participate in this research?

"Indeed, clinicaltrials.gov indicates that this medical experiment is actively searching for participants. It was first published on March 1st 2017 and the latest update was made on October 10th 2022. A total of 148 volunteers must be recruited from one site in order to complete the trial."

Answered by AI

How many individuals are taking part in this medical experiment?

"Verified. Clinicaltrials.gov alludes to the fact that this research is presently enrolling participants, having first been listed on 3rd of March 2017 and most recently updated on 10th October 2022. This study demands 148 individuals from a single site for further investigation."

Answered by AI

Has the FDA approved any Monitoring products or services?

"Due to the Phase 4 trial status of this medication, our team at Power gave Monitoring a rating of 3 on their safety scale. This signifies that it is a safe and approved treatment option."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Heart and Lung Transplants from Hcv-infected Donors to Uninfected Recipients

Woolley, Ann E., Steve K. Singh, Hilary J. Goldberg, Hari R. Mallidi, Michael M. Givertz, Mandeep R. Mehra, Antonio Coppolino, et al.. 2019. “Heart and Lung Transplants from Hcv-infected Donors to Uninfected Recipients”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1812406.

clinicaltrials.govStudy

Transplanting Hepatitis C Positive Organs

Lindsey R. Baden, MD 2017. "Transplanting Hepatitis C Positive Organs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03086044.

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