Clinical trial 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?
This is an investigational antiviral medicine being studied to help prevent Hepatitis B virus infection during lung transplantation. It is designed to stop the Hepatitis B virus from copying itself inside your cells.
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
- This study aims to show that using a special light treatment and antiviral drugs makes it safe to use lungs from donors who have Hepatitis B.
- Who it's for
- People who are waiting to receive a lung transplant from a donor who has Hepatitis B.
- What's involved
- Participants will receive a lung from a donor with Hepatitis B. The lung is treated with ultraviolet (UV) light and antiviral medicines before being transplanted.
- Time commitment
- The source text does not specify the total duration or number of visits required.
- 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;
- 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
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;
- 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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.