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

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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Key information

Conditions

Liver Cirrhosis Blood-Borne Infections Chronic Disease Chronic Hepatitis B Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Fibrosis Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Catholic University, Seoul St Mary Hospital

Seoul, 137-701, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Sample Collection

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.

Primary outcomes

anti-HBs titer

Time frame: up to 6 months

The anti-HBs titer is measured on the day of LT, day 1, week 1, week 4, week 12 and week 24, to determine the pharmacokinetic characteristic of Hepabig I.V. injection

Sponsors and collaborators

Lead sponsor

Dong-Gu Kim

Other

Collaborators

Green Cross Corporation

Registry information

Official study title

An Exploratory Clinical Trial to Evaluate the Pharmacokinetic Characteristics of I.V. Hepabig Injection Used for Prevention of Hepatitis B Relapse After Liver Transplantation

Acronym: LT

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Apr 29, 2014
Registry last updated: Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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