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NCT02125071 Clinical Trial

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

Liver Cirrhosis Clinical Trial

— LT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02125071
Other study ID # I.V. Hepabig injection_IIT
Secondary ID
Status Completed
Phase N/A
First received March 31, 2014
Last updated October 16, 2016
Start date November 2013
Est. completion date September 2015

Study information
Verified date October 2016
Source Seoul St. Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Korea, Republic of The Catholic University, Seoul St Mary Hospital Seoul

Sponsors (2)
Lead Sponsor Collaborator
Dong-Gu Kim Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary anti-HBs titer 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 No
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