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

HBV Clinical Trial

Official title:

Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in HBV Negative Recipients Received Orthotopic Liver Transplant With HBcAb+ Donors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04703465
• Other study ID #: In the application
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: December 2020
• Source: RenJi Hospital
• Contact: Qiang Xia, MD., Ph.D.
• Phone: +8602168383775
• Email: xiaqiang[@]shsmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HBV
• Liver Transplant Disorder

Intervention

Drug:
• Tenofovir Alafenamide 25 MG
Tenofovir Alafenamide 25mg for 48 weeks will be delivered

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 weeks Renal safety of TAF after liver transplantation.	Secondary outcome is to evaluate changes in renal function (Serum Creatinine, eGFR, ß2-MG: Cr, RBP:Cr) at 48 weeks.	48 weeks
Secondary	96 weeks Renal safety of TAF after liver transplantation.	Secondary outcome is to evaluate changes in renal function (Serum Creatinine, eGFR, ß2-MG: Cr, RBP:Cr) at 96 weeks.	96 weeks