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New treatment option for Hepatitis B Virus (HBV)
Official title Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors
ClinicalTrials.gov ID: NCT07189377
What this study is testing
What is Entecavir?
Entecavir is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hepatitis b virus (hbv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Donor Donor lung suitable for transplantation
- HBV SAg positive and/or HBV NAT+ donor Donor
You likely can't join if
- 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)...
- Recipients eligible and listed for lung transplant
- HBV NAT negative
- Provides written informed consent
See the full eligibility criteria
- Donor Donor lung suitable for transplantation
- HBV SAg positive and/or HBV NAT+ donor Donor
- 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...
- Chronic liver disease with \> stage 2 fibrosis
- Participating in another treatment 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).
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.