Study on the Pharmacokinetic Characteristics of I.V. Hepabig Injection Used for Prevention of Hepatitis B Relapse After Liver Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-09-30

Brief Summary

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An exploratory clinical trial to evaluate the pharmacokinetic characteristics of I.V. Hepabig injection used for prevention of hepatitis B relapse after liver transplantation.

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Detailed Description

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Conditions

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Liver Cirrhosis Chronic Hepatitis B

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Hepabig

Those who receiving I.V. Hepabig injection used for prevention of hepatitis B relapse after liver transplantation

Blood Sample Collection

Intervention Type OTHER

Blood Sample Collection before and after the administration of I.V. Hepabig Inj. on LT day(0 day); 1 day after; 1, 4, 12 and 24 weeks after LT.

Interventions

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Blood Sample Collection

Blood Sample Collection before and after the administration of I.V. Hepabig Inj. on LT day(0 day); 1 day after; 1, 4, 12 and 24 weeks after LT.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female ≤18 years old
* Patients who understand the informed consent form and signed the form voluntarily
* Patients who underwent liver transplantation due to HBV related disease and will be treated for prevention of hepatitis B relapse after liver transplantation

Exclusion Criteria

* Multi-organ recipient or reimplantation
* IgA Deficiency
* Serious nephropathy
* Serious cardiovascular system failure within 6 months
* Ischemic or hemolytic anemia
* Condition of immunosuppression and immunodeficiency
* Hypersensitivity or allergic to blood products
* HIV or HCV positive
* Participation to other clinical trial within 3 months
* Pregnancy or breast feeding
* Those who the investigator determines inappropriate to participate

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No