The preventive and therapeutic effect of immunoglobulin on infectious diseases in organ transplant recipients: A prospective randomized controlled study.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-14004865

Enrollment

Unknown

Registered

2014-06-30

Start date

2014-06-30

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

infection

Interventions

Two groups:immunoglobulin vs placebo

Eligibility

Sex/Gender

All

Age

16 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Subjects included in this study should be aged between 16 and 70 years old male and female; 2. All subjects included in this study should receive allogeneic liver transplantation for the first time in our hospital; 3. The liver for transplantation should come from donation of the dead; 4. All subjects included should fully understand the clinical trial and sign a consent form.

Exclusion criteria

Exclusion criteria: 1. Subjects with primary immunodeficiency diseases and/or human immunodeficiency virus (HIV) infection; 2. Subjects with selective immunoglobulin A (IgA) Deficiency; 3. Subjects who have signs of acute infection, including clinical symptoms like fever and cough, as well as proofs of acute infection by laboratory and imageological examinations; 4. Subjects allergic to immunoglobulin or with a history of severe allergic reaction; 5. Subjects with renal insufficiency that requires dialysis; 6. Subjects with diseases of digestive tract, such as chronic diarrhea, which result in low level of globulin; 7. Subjects who have received transplantation with ABO blood group unmatched; 8. Subjects who have received treatment of immunoglobulin within 6 weeks before the transplantation surgery; 9. Subjects with elevated serum globulin within 1 week before the transplantation surgery.

Design outcomes

Primary

Measure	Time frame
IgG level;IgA level;IgM level;C3 level;C4 level;IgG4 level;chain;k chain;infection rate;	—

Secondary

Measure	Time frame
liver function;blood routine examination;Basal metabolism and biochemical;drug concentration;HBsAb titer;hepatitis B-DNA;B ultrasound;Immunosuppressive regimen;Survival;Rejection rate;Hospital cost;	—

Contacts

Public ContactHe Xiaoshun

the First Affiliated Hospital of Sun Yat-sen Unive

gdtrc@163.com+86 020-87306082

Outcome results

None listed

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