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

NCT ID: NCT04703465

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2024-04-01

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.

Detailed Description

We intent to enroll 30 patients who are HBV negative but received HBcAb+ liver. Antiviral treatment with TAF(25mg/d,oral) will be started on the first day after liver transplantation. Post-operative HBV infection is defined with positive HBV marker (HBsAg) and/or positive HBV DNA after liver transplantation. Primary outcome will be evaluated at 48 weeks. All the patients will be followed up for another at least 1 year to evaluate the long term efficacy and safety of TAF.

The primary endpoint is to calculate de novo HBV infection after liver transplantation when treating with TAF. Secondary endpoint is to evaluate the renal safety of TAF after liver transplantation.

Conditions

HBV; Liver Transplant Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

tenofovir alafenamide

tenofovir alafenamide 25mg daily for 48 weeks

Group Type: EXPERIMENTAL

Tenofovir Alafenamide 25 MG

Intervention Type: DRUG

Tenofovir Alafenamide 25mg for 48 weeks will be delivered

Interventions

Tenofovir Alafenamide 25 MG

Tenofovir Alafenamide 25mg for 48 weeks will be delivered

Intervention Type: DRUG

Other Intervention Names

Vemlidy

Eligibility Criteria

Inclusion Criteria

1. Patients with written informed consent.

2. Age ≥12 years old

3. HBV negative recipients (HBV DNA undetectable and HBsAg negative) receiving HBsAg-, HBcAb+ donor liver

Exclusion Criteria

1. Patients underwent liver re-transplantation

2. CKD (CrCl<30 ml/min by MDRD formula)

3. HBV/HCV-related OLT

4. Other solid organs transplant recipients

5. HIV coinfection

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiang Xia, MD., Ph.D.

Role: STUDY_CHAIR

RenJi Hospital

Zhifeng Xi, MD.

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Central Contacts

Qiang Xia, MD., Ph.D.

Role: CONTACT

xiaqiang@shsmu.edu.cn

+8602168383775

Zhifeng Xi, MD.

Role: CONTACT

xizhifeng@renji.com

+8602168383715

Other Identifiers

In the application

Identifier Type: -

Identifier Source: org_study_id