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Active, Not Recruiting

NCT Number: NCT03112044

Lung Transplant HCV, Pilot Study

In this study HCV negative recipients will be transplanted with HCV positive lungs. Investigators will attempt to decrease infectivity rates by performing Normothermic Ex vivo Lung Perfusion (EVLP), which is an approved method of donor lung preservation, assessment and treatment, and could be an excellent platform to reduce/eliminate hepatitis C virus. Patients will be treated by the standard approved direct-acting antivirals (DAAs) if infection occurs. It is planned to enroll 20 patients from the Lung transplant wait list in this study. Patients will be actively followed for 6 months including HCV PCR tests and then for up for 5 years to look for evidence of HCV infection and any liver or extra-hepatic complications, as well as standard post-transplant complications. This will be a single center pilot study.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Transplant Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Health Network Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

About this study

The success of lung transplantation (LTx) is significantly hindered by the lack of sufficient number of available donors. Many potential donor lungs cannot be utilized in clinical transplantation because donors have chronic viral infections such as hepatitis C (HCV) infection. This study will test the possibility of safely transplanting lungs from HCV positive donors. Donor lungs will be subjected to Normothermic Ex vivo Lung Perfusion (EVLP) for 6 hours for organ assessment and reduction of viral load prior to transplantation. After transplantation, recipients will be carefully monitored for HCV infection and if infection occurs, they will be promptly treated with highly effective antiviral therapy using newly approved DAAs. The aim of the study is to show that transplantation of lungs from HCV positive donors is safe in the era of DAAs. The hypothesis is that the rate of HCV transmission to recipients will be lower than previously described due to EVLP pre-treatment and any HCV transmission that does occur will be readily treatable and curable. If successful, the knowledge from this study can have a large impact to patients with end stage organ diseases by providing a large novel source of donors for lung and potentially other organ transplantations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recipients listed for single or bilateral lung transplant
  • HCV Nucleic Acid Amplification Testing (NAT) negative
  • Ability to provide written informed consent

Exclusion criteria

  • Participation in another interventional clinical trial

Treatment and study plan

Sofosbuvir-velpatasvir (400 mg/100 mg)

Drug

Patients will have standard monitoring with HCV RNA and liver panel assessment at 2 week intervals until HCV is undetectable and then at the end of treatment and 3 and 6 months following its completion. Post-operative transplant care and immunosuppression will be carried on as usual transplant practice at Toronto General Hospital.

Other names: Epclusa

Ex Vivo Lung Perfusion (EVLP)

Device

Normothermic EVLP is a method of donor lung preservation, assessment, treatment, and repair of injured organs. This method allows donor lungs to be treated for at least 12h under protective physiological conditions.

Other names: Normothermic EVLP

Primary outcomes

  1. Safety of transplantation from HCV positive donors to HCV negative recipients

    Time frame: 6 months

    Safety of transplantation using HCV positive donors reflected by 6 month survival and being free of HCV by PCR (either due to lack of transmission or as a result of treatment).

Secondary outcomes

  1. Incidence of HCV transmission

    Time frame: 6 months

    Incidence of donor to recipient HCV transmission.

  2. Correlation between viral loads and recipient infection

    Time frame: 6 months

    Correlation between donor viremia, EVLP perfusate virus load (PCR), lung tissue virus load at the end of EVLP (PCR) and recipient infection

  3. Time to viremia development

    Time frame: 6 months

    Interval of time from transplantation to development of viremia

  4. HCV cure rates

    Time frame: 6 months

    HCV cure rates after treatment of infected patients

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

Lung Transplantation Using Hepatitis C Positive Donors to Hepatitis C Negative Recipients: A Pilot Study

Important dates

Study start
2017
Primary completion
2020
Study completion
2027
First posted
Apr 13, 2017
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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