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Prospective study on hepatitis B vaccination in patients transplanted for HBV-related liver diseases

Strategy for diagnosis and therapy of infective diseases influencing the graft survival

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-13003942
Enrollment
Unknown
Registered
2013-12-02
Start date
2013-12-15
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

hepatitis B

Interventions

1:receiving hepatitis B vaccination

Sponsors

the First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. The age of patients should be ranged from 18 to 79 years old, and there is no limitation in gender; 2. Patients transplanted for HBV-related liver diseases or received hepatitis B core antibody (HBcAb)-positive donor livers; 3. Patients who had received the transplant for more than 12 months; 4. No evidence of HBV recurrence, that is seronegative for HBsAg and HBV-DNA; 5. Normal liver function is required. (The parameters of laboratory examination should be less than double of the reference range); 6. There was no severe episode of rejection during the vaccination and no infection occurred in the last month; 7. Patients were in a mild state of immunosuppression, taking single immunosuppressant or multiple immunosuppressants in low doses and steroid was weaned off for at least 6 months; 8. Patients should sign informed consents after full understanding of the trial.

Exclusion criteria

Exclusion criteria: 1. Post-transplant patients with tumor recurrence; 2. Occurrence of biliary complications: biliary stricture, bile leakage, biliary sludge formation, ischemic changes of biliary tract; 3. Occurrence of vascular complications: stenosis of hepatic artery, portal vein or inferior vena cava, hemorrhage, thrombosis; 4. co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus; 5. Recipients with renal insufficiency which requires regular dialysis treatment; 6. Patients used to be diagnosed as organic cardiopathy or arrhythmia; 7. Women with positive result of pregnancy test or in breast feeding period, or the young couple going to give birth to a baby in the near future; 8. Patients used to be hypersensitive to any ingredient of our vaccine.

Design outcomes

Primary

MeasureTime frame
HBsAb tite;

Secondary

MeasureTime frame
liver function;blood routine examination;coagulation routine;Basal metabolism and biochemical;drug concentration;hepatitis B-DNA;B ultrasoun;

Countries

China

Contacts

Public ContactHe Xiaoshun

Organ Transplant Center, the First Affiliated Hospital of Sun Yat-sen University

gdtrc@163.com+86 020-87306082

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026