HCV Positive Lung Transplant with Antiviral Therapy for Hepatitis C

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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of transplantation from HCV positive donors to HCV negative recipients

Secondary study objectives

Correlation between viral loads and recipient infection

HCV cure rates

Incidence of HCV transmission

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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