Efficacy and safety of TAF monoprophylaxis or with HBIG for prevention of HBV activation after liver transplantation: a multicenter randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200062235

Enrollment

Unknown

Registered

2022-07-30

Start date

2022-08-15

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group A:TAF

Group B:TAF+ HBIG

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged>=18 years; 2. No gender limit; 3. HBV infected liver transplantation recipients were HbsAg positive and HBV DNA < 2000 IU/mL at least 6 months before liver transplantation; 4. With the ability to understand and sign informed consent, which must be obtained before the study begins.

Exclusion criteria

Exclusion criteria: 1. Combined with HCV, HDV or HIV infection; 2. Other primary end-stage liver diseases without HBV infection; 3. Patients who have received liver retransplantation; 4. Liver transplant recipients with HbsAg positive donor or HbcAb positive donor; 5. Previously detected gene mutations associated with HBV drug resistance; 6. Graft dysfunction due to any other cause.

Design outcomes

Primary

Measure	Time frame
Hepatitis B surface antigen;	—

Secondary

Measure	Time frame
Hepatitis B virus DNA;Alanine aminotransferase;Serum Creatinine;Adjusted glomerular filtration rate (eGFR);Bone density;	—

Countries

China

Contacts

Public ContactGuo Wenzhi

The First Affiliated Hospital of Zhengzhou University

guowz66@163.com+86 13598062817

Outcome results