NCT00722332

Brief Summary

The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B in combination with antiviral therapy for the prevention of hepatitis B virus (HBV) recurrence following HBV-related orthotopic liver transplant.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4

Geographic Reach
2 countries

16 active sites

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

February 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

5.7 years

First QC Date

July 23, 2008

Last Update Submit

October 30, 2013

Conditions

Hepatitis BLiver Transplantation

Keywords

HBIG (Hepatitis B Immune Globulin)Chronic Hepatitis B RecurrenceLiver Transplant

Outcome Measures

Primary Outcomes (1)

  • Efficacy of HepaGam B in combination with antiviral therapy

    15 month follow-up

Secondary Outcomes (1)

  • Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy

    15 month follow-up

Study Arms (1)

1

EXPERIMENTAL

HBV-related liver transplant patients

Biological: HepaGam B

Interventions

HepaGam BBIOLOGICAL

Hepatitis B Immunoglobulin

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • HBsAg-positive candidates for HBV-related liver transplant
  • Treatment with antiviral therapy before transplantation as per treating physician's recommendation. (NOTE: It is expected that most patients will receive Lamivudine or Adefovir Dipivoxil pre-transplant. In the case of antiviral resistance, an effective alternative antiviral agent(s) must be used.)

You may not qualify if:

  • Multi-organ transplantation recipients
  • Liver re-transplantation except for primary non-function
  • Presence of a hepatoma (larger than 5.0 cm as a solitary node) or 2 to 3 multi-focal nodes (larger than 3.0 cm each) (Milan Criteria) based on information available at baseline visit (CT scan, MRI).
  • Patients requiring an OLT (Orthotopic Liver Transplant)due to fulminant hepatitis B
  • OLT patients receiving a liver graft from a donor that is positive for HBsAg
  • Patients using interferon pre-transplant (as interferon cannot be used post-transplant)
  • History of IgA (immunoglobulin A) deficiency
  • History of hypersensitivity to blood products.
  • HIV or HCV positive
  • Use of an investigational product, or participation in another clinical trial during the course of the study (with the exception of quality-of-life or repository studies)
  • Pregnancy or planned pregnancy during the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Los Angeles, California, 90033, United States

Location

Unknown Facility

Los Angeles, California, 90095, United States

Location

Unknown Facility

Palo Alto, California, 94304, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Burlington, Massachusetts, 01805, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55455, United States

Location

Unknown Facility

Newark, New Jersey, 07101, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

New York, New York, 10029, United States

Location

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

Unknown Facility

Dallas, Texas, 75246, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Montreal, Quebec, H2X3J4, Canada

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

hepatitis B hyperimmune globulin

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

February 1, 2008

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

US(15)CA(1)