MedTrace Logo

Tenofovir Alafenamide for HBV Prophylaxis in HBV(-) Liver Transplant Recipients With HBcAb+ Donors

NCT04703465 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-01-11

No results posted yet for this study

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.

Conditions

  • HBV
  • Liver Transplant Disorder

Interventions

DRUG

Tenofovir Alafenamide 25 MG

Tenofovir Alafenamide 25mg for 48 weeks will be delivered

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Qiang Xia, MD., Ph.D. · RenJi Hospital

  • Zhifeng Xi, MD. · RenJi Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-04-01
Completion
2024-04-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04703465 on ClinicalTrials.gov