- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01513850
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
May 29, 2015 updated by: SK Chemicals Co., Ltd.
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
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.
Study Overview
Detailed Description
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
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Phase 3
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
-
-
Gyunggi-do
-
Seongnam, Gyunggi-do, Korea, Republic of
- SKChemicals
-
-
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 to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hepabulin IV
|
I.V.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HBV(HBsAg) recurrence
Time Frame: 52 weeks
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to recurrence
Time Frame: 52 weeks
|
52 weeks
|
Survival
Time Frame: 52 weeks
|
52 weeks
|
viral Marker of HBV
Time Frame: 52 weeks
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Dong Goo Kim, MD, PhD, St.Mary's Hospital, Catholic University Medical college
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
October 1, 2010
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
January 16, 2012
First Submitted That Met QC Criteria
January 19, 2012
First Posted (Estimate)
January 20, 2012
Study Record Updates
Last Update Posted (Estimate)
June 1, 2015
Last Update Submitted That Met QC Criteria
May 29, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hepabulin IV_LT_lll_2011
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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