Trial record 84 of 434 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Seoul St. Mary's Hospital
Sponsor:
Collaborator:
Green Cross Corporation
Information provided by (Responsible Party):
Dong-Gu Kim, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT02125071
First received: March 31, 2014
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Liver Cirrhosis
Chronic Hepatitis B
Other: Blood Sample Collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • anti-HBs titer [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02125071

Contacts
Contact: Dong Gu Kim, MD, PhD +82-2258-1158 kimdg@catholic.ac.kr
Contact: Seung Hoon Han, MD +82-2-2258-7884 waystolove@catholic.ac.kr

Locations
Korea, Republic of
The Catholic University, Seoul St Mary Hospital Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Dong Gu Kim, MD, PhD    02-2128-1158    kimdg@catholic.ac.kr   
Principal Investigator: Dong Gu Kim, MD, PhD         
Sponsors and Collaborators
Seoul St. Mary's Hospital
Green Cross Corporation
Investigators
Principal Investigator: Dong Gu Kim, MD, PhD The Catholic University, Seoul St Mary Hospital
  More Information

No publications provided

Responsible Party: Dong-Gu Kim, MD, Phd, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02125071     History of Changes
Other Study ID Numbers: I.V. Hepabig injection_IIT
Study First Received: March 31, 2014
Last Updated: April 24, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Cirrhosis
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014