Status:
UNKNOWN
HBV Vaccine in Anti-core Positive Donors After LT
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
University of Padova
Hospital Vall d'Hebron
Conditions:
Hepatitis B Reactivation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Anti-HBc positive liver donors frequently have occult HBV infection, and several studies in HBsAg-negative subjects have shown that there is often the detection in the liver of covalently closed circu...
Detailed Description
HYPOTHESIS The hypothesis of the study is that active immunization may be successful in up to 20% of patients who received an anti-HBc+ liver during transplantation after the first vaccination schedul...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years- old.
- HBsAg-negative pre-transplantation
- Liver transplant recipients; more than 2 years from the date of LT
- Transplantation of a graft from an HBV anti-core positive donor
- Patients should be under nucleoside analogue therapy with Lamivudine, Tenofovir or Entecavir
- Stable immunosuppressive therapy during the last 6 months
- Baseline anti-HBs levels \<100 IU/L (HBV vaccination while on the waiting list is allowed and will be recorded)
- Willingness to participate in the study and written inform consent
Exclusion
- • HBsAg positive at any time post-transplantation
- HBV-DNA positive at any time post-transplantation
- Any HBIG dose during the last 12 months
- HBV vaccination after liver transplantation
- Spontaneous or vaccine-induced post-transplant anti-HBs titers ≥ 100 UI/L
- Any rejection episode during the last 12 months
- Positive HCV-RNA at time of vaccination
- HCV therapy with direct acting antivirals within the previous 12 months
- HIV coinfection
- Advanced fibrosis after LT (liver stiffness measurement ≥ 9.5 kPa)
- Pregnancy
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04442841
Start Date
September 1 2020
End Date
January 1 2023
Last Update
July 31 2020
Active Locations (1)
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1
Liver Unit, Hospital Clinic
Barcelona, Spain, 08036