A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients

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

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-03-31

Brief Summary

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The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.

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Detailed Description

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A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients

Conditions

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Hepatitis B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hepabulin IV

Group Type EXPERIMENTAL

Hepabulin IV

Intervention Type DRUG

I.V.

Interventions

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Hepabulin IV

I.V.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No