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Direct-acting Antiviral

HCV Positive Lung Transplant with Antiviral Therapy for Hepatitis C

Q: Are there any openings for prospective participants in this trial?

<p>The clinicaltrials.gov page for this medical trial indicates that it is not currently recruiting participants, as the last update was on November 10th 2022 and the study's commencement date was September 19th 2017. Nevertheless, 310 other trials are actively looking for patients right now.</p>

Q: What is the maximum enrollment capacity for this research initiative?

<p>This research project is no longer accepting new participants. Initially posted on September 19th, 2017 and last edited November 10th 2022; there are numerous alternative studies suitable for those seeking to take part in clinical trials. There are currently 283 trials actively engaging patients who have <a href="https://www.withpower.com/clinical-trials/hepatitis-c">hepatitis c</a> as well as 27 EVLP initiatives that require volunteers.</p>

Phase < 1

Waitlist Available

Led By Marcelo Cypel, MD MSc FRCSC

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Recipients listed for single or bilateral lung transplant

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will test if transplanting HCV positive lungs into HCV negative recipients, and using a treatment to reduce/eliminate the virus, is safe and effective.

Who is the study for?

This trial is for HCV negative patients on the lung transplant waitlist who can consent to receiving HCV positive lungs. They will be monitored closely and treated with antivirals if they get infected.Check my eligibility

What is being tested?

The study tests whether treating donated HCV positive lungs with EVLP before transplant reduces infection rates in recipients. If patients do get infected, standard antiviral drugs are used as treatment.See study design

What are the potential side effects?

Potential side effects may include those associated with the antiviral medication Sofosbuvir-velpatasvir, such as headache, fatigue, nausea, and difficulty sleeping.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on the list for a lung transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Safety of transplantation from HCV positive donors to HCV negative recipients

Secondary outcome measures

Correlation between viral loads and recipient infection

HCV cure rates

Incidence of HCV transmission

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: HCV+ lung transplant to HCV- recipientsExperimental Treatment2 Interventions

HCV+ donor lungs will be treated with Normothermic Ex Vivo Lung Perfusion (EVLP) in order to reduce viral load and minimize risk of HCV transmission. Patients who become viremic defined as at least two consecutive positive samples will receive sofosbuvir/velpatasvir 400 mg/100 mg (Epclusa) for 12 weeks.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor

1,082 Previous Clinical Trials

842,727 Total Patients Enrolled

121 Trials studying Infections

61,473 Patients Enrolled for Infections

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,464 Total Patients Enrolled

13 Trials studying Infections

1,775 Patients Enrolled for Infections

Marcelo Cypel, MD MSc FRCSCPrincipal InvestigatorUniversity Health Network, Toronto

Frequently Asked Questions

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

Are there any openings for prospective participants in this trial?

"The clinicaltrials.gov page for this medical trial indicates that it is not currently recruiting participants, as the last update was on November 10th 2022 and the study's commencement date was September 19th 2017. Nevertheless, 310 other trials are actively looking for patients right now."

Answered by AI

What is the maximum enrollment capacity for this research initiative?

"This research project is no longer accepting new participants. Initially posted on September 19th, 2017 and last edited November 10th 2022; there are numerous alternative studies suitable for those seeking to take part in clinical trials. There are currently 283 trials actively engaging patients who have hepatitis c as well as 27 EVLP initiatives that require volunteers."

Answered by AI

Recent research and studies

The Lancet Respiratory MedicineJournal

Prevention of Viral Transmission During Lung Transplantation with Hepatitis C-viraemic Donors: An Open-label, Single-centre, Pilot Trial

Cypel, Marcelo, Jordan J Feld, Marcos Galasso, Rafaela V Pinto Ribeiro, Nikki Marks, Magdalena Kuczynski, Deepali Kumar, et al.. 2020. “Prevention of Viral Transmission During Lung Transplantation with Hepatitis C-viraemic Donors: An Open-label, Single-centre, Pilot Trial”. The Lancet Respiratory Medicine. Elsevier BV. doi:10.1016/s2213-2600(19)30268-1.

clinicaltrials.govStudy

Lung Transplant HCV, Pilot Study

2017. "Lung Transplant HCV, Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03112044.

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