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

October 16, 2016 updated by: Dong-Gu Kim

An Exploratory Clinical Trial to Evaluate 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University, Seoul St Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepabig
Those who receiving I.V. Hepabig injection used for prevention of hepatitis B relapse after liver transplantation
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-Gu Kim

Collaborators

Green Cross Corporation

Investigators

  • Principal Investigator: Dong Gu Kim, MD, PhD, The Catholic University, Seoul St Mary Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 16, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I.V. Hepabig injection_IIT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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