Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT01513850
Eligibility Criteria:
Inclusion Criteria:
* HBsAg Positive candidate for HBV-related liver transplant
* Primary, single organ recipients
* written informed consent
Exclusion Criteria:
* acute renal failure, Serum creatinin \>1.5\*ULN
* severe cardiac disease or other significant disease
* HAV, HCV or HIV positive
* Immunoglobulin A deficiency.
* History of hypersensitivity to Human Immunoglobulin.
* History of cancer within 5 years. (without HCC)
* History of alcohol or/and drug abuse.
* History organ transplantation.
* Within 30 days, participation in another clinical trial and use of an investigational product.
* Subject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01513850
Study Brief:
Protocol Section:
NCT01513850