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

NCT02125071 | Completed

• 1 other identifier: I.V. Hepabig injection_IIT
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Hepabig

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

Other: Blood Sample Collection

Interventions

Blood Sample Collection OTHER

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.

Hepabig

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-Gu Kim: lead
• Green Cross Corporation: collaborator

Study Sites (1)

The Catholic University, Seoul St Mary Hospital

Seoul, Seoul, 137-701, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Liver Cirrhosis; Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Chronic Disease; Disease Attributes

Study Officials

• Dong Gu Kim, MD, PhD

  The Catholic University, Seoul St Mary Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Phd

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 29, 2014
• Study Start: November 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

KR (1)