Tenofovir Alafenamide for HBV Prophylaxis in HBV(-) Liver Transplant Recipients With HBcAb+ Donors
Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in HBV Negative Recipients Received Orthotopic Liver Transplant With HBcAb+ Donors
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
Liver transplantation is currently the only effective way to treat end-stage liver disease.The shortage of donor liver is still the major problem. Incidence of HBcAb+ varies between different regions. The HBcAb positive rate could be as high as 52% in China.HBcAb positive donor liver may enlarge donor pool and thus save ESLD patients. However, the use of HBcAb positive donor liver may induce HBV infection in hepatitis B negative recipient after liver transplantation. Tenofovir alafenamide (TAF) has better stability in plasma and higher liver targeting property in comparison with tenofovir (TDF), with an extra amide bond, which allows strong antiviral effect with much less doses and reducing the renal and bone injury. Our study intends to evaluate the efficacy and safety of HBV prophylaxis treatment of TAF in HBV negative patients after receiving HBcAb positive donor livers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedJanuary 11, 2021
December 1, 2020
1 year
January 8, 2021
January 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
De novo HBV infected rate after liver transplantation at 48 weeks
Primary outcome is to calculate de novo HBV infection after liver transplantation when treating with TAF.
48 weeks
Secondary Outcomes (2)
48 weeks Renal safety of TAF after liver transplantation.
48 weeks
96 weeks Renal safety of TAF after liver transplantation.
96 weeks
Study Arms (1)
tenofovir alafenamide
EXPERIMENTALtenofovir alafenamide 25mg daily for 48 weeks
Interventions
Tenofovir Alafenamide 25mg for 48 weeks will be delivered
Eligibility Criteria
You may qualify if:
- Patients with written informed consent.
- Age ≥12 years old
- HBV negative recipients (HBV DNA undetectable and HBsAg negative) receiving HBsAg-, HBcAb+ donor liver
You may not qualify if:
- Patients underwent liver re-transplantation
- CKD (CrCl\<30 ml/min by MDRD formula)
- HBV/HCV-related OLT
- Other solid organs transplant recipients
- HIV coinfection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Qiang Xia, MD., Ph.D.
RenJi Hospital
- PRINCIPAL INVESTIGATOR
Zhifeng Xi, MD.
RenJi Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2021
First Posted
January 11, 2021
Study Start
April 1, 2021
Primary Completion
April 1, 2022
Study Completion
April 1, 2024
Last Updated
January 11, 2021
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share