Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors (CLEAR-HBV)

University Health Network, Toronto

Status and phase: Not yet enrolling; Phase 4

Conditions: Lung Transplant Recipient; Hepatitis B Virus (HBV)

Treatments: Device: EVLP UV Light Treatment; Drug: Entecavir; Biological: HBIG

Study type: Interventional

Funder types: Other

Identifiers

NCT07189377

24-6051

Details and patient eligibility

About

The aim of the study is to show that transplantation of lungs from Hepatitis B-infected donors is safe when using EVLP with UV light inactivation plus antivirals

Full description

The success of transplantation is significantly hindered by the lack of sufficient available donors. Many potential donor organs are not fully utilized in clinical transplantation because donors have chronic viral infections. Currently, donors with chronic hepatitis B virus (HBV) infection are typically excluded if the donor is NAT or Surface Ag positive. HBcAb+ve donors are routinely used, but NAT positive donors are typically not used. The Toronto lung transplant program commonly applies Ex Vivo Lung Perfusion (EVLP) to organs. This allows for treatment of organs prior to transplantation. The investigators have shown that UV light administered on the EVLP circuit can substantially decrease the amount of infectious virus. Such a strategy was previously employed with hepatitis C virus. The aim of the study is to show that transplantation of organs from HBV NAT+ve donors is safe with the use of UV light treatment on EVLP combined with post-transplant antivirals for the recipient (HBIG and entecavir). The investigators hypothesize that rates of HBV transmission to recipients will be prevented by the use of this approach and any HBV transmission that does occur will be readily treatable. This will be a small pilot study to determine the feasibility of this approach. If successful, the knowledge from this study can have an important impact on patients awaiting lung transplant by providing a strategy for use of HBV donors for organ transplantation.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Donor Inclusion Criteria

• Donor lung suitable for transplantation
• HBV Core Antibody positive, HBV NAT+ donor

Donor Exclusion Criteria

• HIV positive
• HTLV 1/2 positive;
• Any medical issues in the donor that would normally clinically exclude the donor (e.g. history of cancer, evidence of organ dysfunction, etc).

Recipient inclusion Criteria:

• Recipients eligible and listed for lung transplant
• HBV NAT negative
• Provides written informed consent
• Has received at least 3 prior doses of Hepatitis B vaccine or anti-HBs>=10 IU/mL
• Patients with other co-morbid conditions (such as diabetes, autoimmune disease, renal dysfunction) will remain eligible provided they are otherwise medically suitable for transplantation. The exception to this will be patients with significant liver disease as outlined below.

Recipient exclusion Criteria:

• Chronic liver disease with > stage 2 fibrosis
• Participating in another interventional clinical trial
• Recipient listed for combined transplant (e.g., heart-lung, lung-liver)
• Known allergy or contraindication to any of the antiviral medications
• Hepatitis B surface antigen (HBsAg) or Hepatitis B core Ab positive pre-transplant (indicates already HBV infected).
• HIV positive
• Patients with a low level of serum IgA pre-transplant (this may be a risk factor for sensitivity reaction to HBIG).

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

UV Light + Short-course Entecavir/HBIG

Experimental group

Description:

Patients will receive lungs from HBV NAT+ donors, which will be treated with UV light therapy during ex-vivo perfusion. Patients will also receive Entecavir and HBIG prophylaxis in the immediate peri-operative period.

Treatment:

Biological: HBIG

Drug: Entecavir

Device: EVLP UV Light Treatment