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

Completed

• Conditions: Chronic Hepatitis B; Liver Cirrhosis
• Interventions: Other: Blood Sample Collection

• Registration Number: NCT02125071
• Lead Sponsor: Dong-Gu Kim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-03-31
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-29
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-16
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepabig	Blood Sample Collection	Those who receiving I.V. Hepabig injection used for prevention of hepatitis B relapse after liver transplantation

Primary Outcome Measures

Name	Time	Method
anti-HBs titer	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

Trial Locations

Locations (1)

The Catholic University, Seoul St Mary Hospital; 🇰🇷 Seoul, Korea, Republic of