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Direct-acting Antiviral
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 belowSelect...
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
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 moreAwards & 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.
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Who is running the clinical trial?
Gilead SciencesIndustry Sponsor
1,137 Previous Clinical Trials
867,957 Total Patients Enrolled
124 Trials studying Infections
69,479 Patients Enrolled for Infections
University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,296 Total Patients Enrolled
13 Trials studying Infections
1,775 Patients Enrolled for Infections
Marcelo Cypel, MD MSc FRCSCPrincipal InvestigatorUniversity Health Network, Toronto