Lung Transplant HCV, Pilot Study

NCT03112044 | Active Not Recruiting Early Phase 1

• 2 other identifiers: 16-6084UHNTID006
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Transplant Infection; Hepatitis C

Keywords

Lung; Transplant; Hepatitis C; DAAs; Epclusa

Outcome Measures

Primary Outcomes (1)

• Safety of transplantation from HCV positive donors to HCV negative recipients

  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).

  6 months

Secondary Outcomes (4)

• Incidence of HCV transmission

  6 months

• Correlation between viral loads and recipient infection

  6 months

• Time to viremia development

  6 months

• HCV cure rates

  6 months

Study Arms (1)

HCV+ lung transplant to HCV- recipients

EXPERIMENTAL

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); Device: Ex Vivo Lung Perfusion (EVLP)

Interventions

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.

Also known as: Epclusa

HCV+ lung transplant to HCV- recipients

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.

Also known as: Normothermic EVLP

HCV+ lung transplant to HCV- recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Participation in another interventional clinical trial

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Gilead Sciences: collaborator

Study Sites (1)

University Health Network Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (1)

• Cypel M, Feld JJ, Galasso M, Pinto Ribeiro RV, Marks N, Kuczynski M, Kumar D, Bahinskaya I, Bagnato VS, Kurachi C, Slutsky AS, Yeung JC, Donahoe L, de Perrot M, Yasufuku K, Pierre A, Binnie M, Chaparro C, Martinu T, Chen M, Tikkanen J, Chow CW, Sidhu A, Waddell TK, Keshavjee S, Singer LG, Humar A. Prevention of viral transmission during lung transplantation with hepatitis C-viraemic donors: an open-label, single-centre, pilot trial. Lancet Respir Med. 2020 Feb;8(2):192-201. doi: 10.1016/S2213-2600(19)30268-1. Epub 2019 Oct 9.

  PMID: 31606437 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Marcelo Cypel, MD MSc FRCSC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 13, 2017
• Study Start: September 19, 2017
• Primary Completion: January 2, 2020
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)