Hepatitis B recurrence after liver transplantation
Conditions
Interventions
Group 1:Withdraw hepatitis B immune globulin after short term use
Group 2:Hepatitis B therapy with Tenofovir Alafenamide Fumarate
Sponsors
Zhongshan Hospital, Fudan University, Shanghai,China
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Male or non-pregnant female patients aged between 18 and 65 years; 2) The donor liver is negative for HBeAg and HBsAg, and other virological examinations meet the criteria of the donor liver; 3) The subjects receive liver transplantation for the first time, the primary disease is hepatitis B-related liver disease, and the liver cancer patients are within the "Fudan Standard"; 4) One month after transplantation, total bilirubin =100 IU/L; HBV-DNA below the detection limit; 5) Patients voluntarily participate in the research with good compliance.
Exclusion criteria
Exclusion criteria: 1) Patients with severe heart, lung, and kidney diseases; 2) Primary liver cancer has invaded large vessels such as vena cava, main trunk or left and right branches of portal vein, and hepatic vein; 3) Serious transplant-related complications (such as severe acute rejection, bile duct and vascular complications require intervention or surgery) after transplantation; 4) The patients have other types of viral hepatitis; 5) Retransplantation or combined organ transplantation; 6) Allergic to HBIG; 7) Participated in other clinical trials in the last 3 months; 8) No legal capacity or limited legal capacity; 9) Any other circumstances that the investigator considers the patients inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative recurrence rate of hepatitis B; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events related to hepatitis B treatment;Patients’ overall survival (OS);Changes in subjects' quality of life; | — |
Countries
China
Contacts
Public ContactHe Yifeng
Zhongshan Hospital, Fudan University
Outcome results
None listed