Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant

NCT05063071 | Unknown Phase 4

• 1 other identifier: TAF-Prophylaxis-Post Liver Tx
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

TAF treatment for HBV prophylaxis could lead to significant reduction in ALT and significant improvement in renal function. However, data are scarce regarding to TAF monotherapy without HBIG for HBV prophylaxis in post orthotopic liver transplant with HBV-related disease. This study is based on a real-world, multi-center, prospective study to assess the effectiveness and safety of TAF for HBV prophylaxis, which will fill in gaps with TAF monotherapy without HBIG in post liver transplant.

Conditions

HBV; POST LIVER TRANSPLANT

Outcome Measures

Primary Outcomes (1)

• HBV DNA undetectable rate at week 48.

  evaluate the HBV DNA undetectable rate (defined as HBV DNA \< 20 IU/mL) at week 48 after liver transplant.

  48 weeks

Secondary Outcomes (11)

• HBV DNA undetectable rate at week 96

  96 weeks

• HBsAg negative rate at week 48

  48 weeks

• HBsAg negative rate at week 96

  96 weeks

• ALT normalization rate at week 48

  48 weeks

• ALT normalization rate at week 96

  96 weeks

Study Arms (1)

TAF monotherapy without HBIG

EXPERIMENTAL

The standard dose of TAF 25mg daily was used. TAF can be used on the first day after orthotopic liver transplantation. No HBIG was used before, during, or after transplantation; and therapeutic vaccination was not routinely used.

Drug: Tenofovir Alafenamide 25 MG

Interventions

Tenofovir Alafenamide 25 MG DRUG

After orthotopic liver transplant, all patients will receive Tenofovir Alafenamide monotherapy without HBIG for HBV Prophylaxis.

TAF monotherapy without HBIG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be capable of understanding and signing written informed consent; Before commencing the study procedure, participants must obtain informed consent. If the patient is hepatic Coma, the family member shall sign the written informed consent.
• ≥18 years old.
• Orthotopic liver transplant for HBV-related disease (such as HCC, DCC or liver failure). Patients were all positive for HBsAg for at least 6 months prior to liver transplantation.
• HBV DNA ≤ 2000 IU/mL before orthotopic liver transplant . (Including patients who received or did not receive oral antiviral therapy before liver transplantation)

You may not qualify if:

• Post OLT patients received HBIG
• Other solid organs transplant recipients
• HCV, HDV or HIV coinfection
• Other primary end-stage liver diseases (PBC, PSC, etc)
• Patients with underwent liver re-transplantation
• Liver grafts from HBsAg+ donors
• Graft dysfunction of any other causes
• HCC with primary portal vein thrombus

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Interventions

tenofovir alafenamide

Study Officials

• Jian Zhou

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: September 30, 2021
• Study Start: July 29, 2021
• Primary Completion: July 29, 2022
• Study Completion: December 29, 2022
• Last Updated: September 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)