Lung Transplant HCV, Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03112044|
Recruitment Status : Active, not recruiting
First Posted : April 13, 2017
Last Update Posted : April 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Transplant Infection Hepatitis C||Drug: Sofosbuvir-velpatasvir (400 mg/100 mg) Device: Ex Vivo Lung Perfusion (EVLP)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Investigators aim to transplant 20 HCV- recipients with end-stage lung disease from transplant wait-list using lungs from HCV+ donors. Donor lungs will be selected based on usual donor selection criteria evaluating blood gas analysis, chest imaging, bronchoscopy findings, and assessment in the operating room. Once lungs meet criteria for transplantation, they will be retrieved in standard fashion, transported to Toronto General Hospital in cold static preservation, placed on EVLP for 6 hours, and transplanted to consented recipients.|
|Masking:||None (Open Label)|
|Official Title:||Lung Transplantation Using Hepatitis C Positive Donors to Hepatitis C Negative Recipients: A Pilot Study|
|Actual Study Start Date :||September 19, 2017|
|Actual Primary Completion Date :||January 2, 2020|
|Estimated Study Completion Date :||April 17, 2021|
Experimental: HCV+ lung transplant to HCV- recipients
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.
Drug: Sofosbuvir-velpatasvir (400 mg/100 mg)
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 Name: Epclusa
Device: Ex Vivo Lung Perfusion (EVLP)
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 Name: Normothermic EVLP
- 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).
- Incidence of HCV transmission [ Time Frame: 6 months ]Incidence of donor to recipient HCV transmission.
- 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
- Time to viremia development [ Time Frame: 6 months ]Interval of time from transplantation to development of viremia
- HCV cure rates [ Time Frame: 6 months ]HCV cure rates after treatment of infected patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112044
|University Health Network Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2N2|
|Principal Investigator:||Marcelo Cypel, MD MSc FRCSC||University Health Network, Toronto|