NCT01513850

Brief Summary

The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

3.4 years

First QC Date

January 16, 2012

Last Update Submit

May 29, 2015

Conditions

Hepatitis B

Keywords

Liver TransplantationHBVHBV RecurrenceHBsAg Positive

Outcome Measures

Primary Outcomes (1)

  • HBV(HBsAg) recurrence

    52 weeks

Secondary Outcomes (3)

  • Time to recurrence

    52 weeks

  • Survival

    52 weeks

  • viral Marker of HBV

    52 weeks

Study Arms (1)

Hepabulin IV

EXPERIMENTAL
Drug: Hepabulin IV

Interventions

Hepabulin IVDRUG

I.V.

Hepabulin IV

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HBsAg Positive candidate for HBV-related liver transplant
  • Primary, single organ recipients
  • written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SKChemicals

Seongnam, Gyunggi-do, South Korea

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Dong Goo Kim, MD, PhD

    St.Mary's Hospital, Catholic University Medical college

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2012

First Posted

January 20, 2012

Study Start

October 1, 2010

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 1, 2015

Record last verified: 2015-05

Locations

KR(1)