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Relationship between immune status and hepatitis B vaccination active immune reconstitution after liver transplantation in patients with hepatitis B related liver disease

Relationship between immune status and hepatitis B vaccination active immune reconstitution after liver transplantation in patients with hepatitis B related liver disease

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018209
Enrollment
Unknown
Registered
2018-09-05
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-09-10

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

Conditions

Liver transplant recipient, hepatitis B

Interventions

A:Immune state, HBIG, nucleotide (s) protocol 1
B:Immune state, small dose of HBV vaccine, HBIG, nucleotide (s) protocol 2
C:Immune state, small dose of HBV vaccine, nucleotide(s) protocol 3
D:Immune state, large dose of HBV vaccine, HBIG, nucleotide (s) protocol 4
E:Immune state, large dose of HBV vaccine, nucleotide(s) protocol 5

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Informed consent signed by the patient or his legal guardian; 2. male or female patients aged 18~70 years; 3. preoperative HBV-DNA replication is negative, HBsAg positive, HBsAb negative, and postoperative hepatitis B surface antibody of patient are positive 3 years after liver transplantation; 4. the main detection indexes of the patients were: 1) liver function: normal; 2) renal function: normal.

Exclusion criteria

Exclusion criteria: 1. Women who are in pregnancy (urine / blood pregnancy test positive) or lactating; 2. Men or women with pregnancy plans in the last year; 3. Patients who had uncontrollable infection during 4 weeks before the entry of the group; 4. HIV infected patients; 5. Patients are allergic, allergic to macromolecules, such as antibodies or cytokines; 6. Patients participated in other clinical trials before entering the group; 7. Patients with systemic use of hormones before entering the group (except for inhaled corticosteroids); 8. patients suffering from mental illness; 9. patients have drug abuse / addiction; 10. There are other inappropriate situations for patients judged by the researchers.

Design outcomes

Primary

MeasureTime frame
anti-HBs titier;HBVcccDNA;

Countries

China

Contacts

Public ContactShen Zhongyang

Tianjin First Central Hospital

hlsong26@163.com+86 13502038977

Outcome results

None listed

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