NCT00895713

Brief Summary

The purpose of this study is to determine if treatment with intramuscular hepatitis B virus immune globulin Grifols, a new specific hepatitis B immune globulin, is effective and safe for the prevention of hepatitis B virus recurrence after orthotopic liver transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

2 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

November 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
Last Updated

May 8, 2009

Status Verified

May 1, 2009

Enrollment Period

7 months

First QC Date

May 7, 2009

Last Update Submit

May 7, 2009

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis BHBVAnti-hepatitis B antibodiesImmunoglobulinsliver transplantationProtective levelsRecurrenceIntramuscular

Outcome Measures

Primary Outcomes (1)

  • Mean trough serum HBsAg Ab titer

    Months 4-6

Secondary Outcomes (5)

  • HBV recurrence percentage in long-term OLT recipients during i.m. HBIG Grifols treatment period

    Week 2 - 7 months

  • Mean trough HBsAg Ab titer

    4 months

  • Individualised trough HBsAg Ab titer

    Week 2 - 7 months

  • Number of subjects with serum HBV DNA-positive samples by DNA PCR-amplification assay

    Week 2 - 7 months

  • Safety and tolerability

    7 months

Study Arms (1)

im HBIG Grifols

EXPERIMENTAL
Drug: intramuscular hepatitis B virus immune globulin

Interventions

intramuscular hepatitis B virus immune globulinDRUG

Biweekly intramuscular doses of 2000 IU administered during 6 consecutive months

Also known as: Igantibe
im HBIG Grifols

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female.
  • Age \> 18 years and \< 70 years.
  • Serum HBsAg-positive within 3 months before transplantation.
  • Continuous and interrupted prophylaxis with HBIG after an-hepatic phase as part of the subject clinical care.
  • Signed informed consent.

You may not qualify if:

  • Serum HBeAg-positive within 3 months before transplantation.
  • Serum HBV DNA-positive by standard DNA hybridisation assay (lower detection limit 105 genomes/ml), or by any less sensitivity technique, within 3 months before transplantation.
  • Unknown serum HBV replication status (no data about HbeAg and HBV DNA) within 3 months before transplantation.
  • Previous recurrence of HBV in the transplanted liver defined by serum HBV DNA- positive by sensitive hybridisation (lower detection limit 105 genomes/ml) assay or any less sensitive technique, and/or serum HBeAg-positive, and/or serum HBsAg-positive.
  • Re-transplanted liver even for reasons not related to HBV infection.
  • Life-expectancy less than 1 year.
  • VHC infection.
  • HIV type 1 or type 2 infection.
  • Acute HAV infection.
  • Intolerance or allergy to any i.m. HBIG Grifols containing substance (glycine, sodium chloride, sterile water for injection, homologous human immune globulin).
  • History of SAEs related to the administration of human blood-derived products.
  • History of frequent AEs, even non-serious, related to the administration of human blood-derived products.
  • Selective IgA deficiency with Abs against IgA.
  • Platelet count \< 50 x 109/L.
  • Prothrombin time (PT) \< 60%.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cisanello Hospital. (University of Pisa).

Pisa, Italy

Location

Ospedaliera Molinette

Torino, Italy

Location

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis BRecurrence

Interventions

igantibe

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Franco Filipponi, Prof. MD

    Liver Transplantation Co-ordinating Section. Cisanello Hospital. (University of Pisa).

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

November 1, 2004

Primary Completion

June 1, 2005

Study Completion

July 1, 2005

Last Updated

May 8, 2009

Record last verified: 2009-05

Locations

IT(2)