Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver Transplantation

This study has been completed.
Sponsor:
Information provided by:
Grifols Biologicals Inc.
ClinicalTrials.gov Identifier:
NCT00895713
First received: May 7, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hepatitis B, Chronic
Drug: intramuscular hepatitis B virus immune globulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Intramuscular Hepatitis B Virus Immune Globulin Grifols for the Prevention of Hepatitis B Virus Recurrence After Orthotopic Liver Transplantation.

Resource links provided by NLM:


Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • Mean trough serum HBsAg Ab titer [ Time Frame: Months 4-6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HBV recurrence percentage in long-term OLT recipients during i.m. HBIG Grifols treatment period [ Time Frame: Week 2 - 7 months ] [ Designated as safety issue: No ]
  • Mean trough HBsAg Ab titer [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Individualised trough HBsAg Ab titer [ Time Frame: Week 2 - 7 months ] [ Designated as safety issue: No ]
  • Number of subjects with serum HBV DNA-positive samples by DNA PCR-amplification assay [ Time Frame: Week 2 - 7 months ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: November 2004
Study Completion Date: July 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: im HBIG Grifols Drug: intramuscular hepatitis B virus immune globulin
Biweekly intramuscular doses of 2000 IU administered during 6 consecutive months
Other Name: Igantibe

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female.
  2. Age > 18 years and < 70 years.
  3. OLT recipient for HBV infection-related disease for > 18 months before inclusion in the clinical trial.
  4. Serum HBsAg-positive within 3 months before transplantation.
  5. Serum HBsAg-negative just before inclusion in the clinical trial.
  6. Serum HbeAg-negative just before inclusion in the clinical trial.
  7. Serum HBV DNA-negative by DNA PCR-amplification assay (lower detection limit 102 genomes/ml) just before inclusion in the clinical trial.
  8. Continuous and interrupted prophylaxis with HBIG after an-hepatic phase as part of the subject clinical care.
  9. Trough serum HBsAg Ab (HBsAg IgG) titer (immediately pre-dose) > 150 I.U./l in at least 2 consecutive determinations within last 3 months before inclusion in the clinical trail.
  10. Signed informed consent.

Exclusion Criteria:

  1. Serum HBsAg-positive just before inclusion in the clinical trial.
  2. Serum HBeAg-positive within 3 months before transplantation.
  3. 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.
  4. Unknown serum HBV replication status (no data about HbeAg and HBV DNA) within 3 months before transplantation.
  5. 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.
  6. Re-transplanted liver even for reasons not related to HBV infection.
  7. Evidence of hepatocellular carcinoma in the transplanted liver, or metastatic disease, at time of inclusion in the clinical trial.
  8. Evidence of graft rejection at time of inclusion in the clinical trial.
  9. Life-expectancy less than 1 year.
  10. VHC infection.
  11. HIV type 1 or type 2 infection.
  12. Acute HAV infection.
  13. Previous treatment with i.m. HBIG Grifols within 3 months before inclusion in the clinical trial.
  14. Intolerance or allergy to any i.m. HBIG Grifols containing substance (glycine, sodium chloride, sterile water for injection, homologous human immune globulin).
  15. History of SAEs related to the administration of human blood-derived products.
  16. History of frequent AEs, even non-serious, related to the administration of human blood-derived products.
  17. Selective IgA deficiency with Abs against IgA.
  18. Platelet count < 50 x 109/L.
  19. Prothrombin time (PT) < 60%.
  20. Activated partial thromboplastin time (APTT) ratio > 1.5.
  21. Any haemostatic abnormality contraindicating i.m. injection according to investigator's judgement.
  22. Haemoglobin < 11 g/dl.
  23. Alcohol or drug abuse at the moment or within 1 year before inclusion in the clinical trial.
  24. Pregnant woman or woman who is expecting to be pregnant within 1 year after inclusion in the clinical trial.
  25. Breast-feeding woman.
  26. Any severe acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator, makes the subject inappropriate for entry in this clinical trial.
  27. Impossibility to donate a serum sample before the first investigational product administration.
  28. Planned treatment with Ig other than i.m. HBIG Grifols within the clinical trial period.
  29. Planned modification, during the clinical trial period, of the prophylactic regimen with nucleoside analogues followed by the subjects, if any, within last 3 months before inclusion in the clinical trial.
  30. The subject has been previously admitted to this clinical trial.
  31. Participation in other clinical trial within 3 months before study inclusion.
  32. Subject's incapacity of giving consent personally.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895713

Locations
Italy
Cisanello Hospital. (University of Pisa).
Pisa, Italy
Ospedaliera Molinette
Torino, Italy
Sponsors and Collaborators
Instituto Grifols, S.A.
Investigators
Principal Investigator: Franco Filipponi, Prof. MD Liver Transplantation Co-ordinating Section. Cisanello Hospital. (University of Pisa).
  More Information

No publications provided

Responsible Party: Antonio Páez, MD, Instituto Grifols S.A.
ClinicalTrials.gov Identifier: NCT00895713     History of Changes
Other Study ID Numbers: IG302
Study First Received: May 7, 2009
Last Updated: May 7, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by Grifols Biologicals Inc.:
Hepatitis B
HBV
Anti-hepatitis B antibodies
Immunoglobulins
liver transplantation
Protective levels
Recurrence
Intramuscular

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Recurrence
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Disease Attributes
Pathologic Processes
Hepatitis, Chronic
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014