Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation

This study has been completed.
Sponsor:
Information provided by:
Grifols Biologicals Inc.
ClinicalTrials.gov Identifier:
NCT00838071
First received: February 5, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 5, 2009
February 5, 2009
October 2003
July 2004   (final data collection date for primary outcome measure)
To determine if after 4 months of continuous monthly administration of HB-IVIG Grifols, the anti-hepatitis B antibodies contained in the product reach levels considered as protective, and to assess if these levels are kept constant during 2 more months. [ Time Frame: At months 4, 5, and 6 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • To determine the in vivo recovery of 6 consecutive doses of HB-IVIG Grifols and demonstrate that it remains constant for each dose. [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
  • To determine various pharmacokinetic parameters after 6 administrations of HB-IVIG Grifols [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
  • To determine the incidence of recurrences during the treatment [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
  • To evaluate tolerance to the administration of HB-IVIG Grifols [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: Yes ]
  • To confirm the viral safety of the product supervising viral markers [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation
Evaluation of Anti-Hepatitis B Antibodies Levels in Serum After the Intravenous Administration of Specific Anti-Hepatitis B Immunoglobulin (IGIV-HB Grifols) in Patients Having Previously Undergone Liver Transplantation

The purpose of this study is to determine whether protective anti-HB serum levels are maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific hepatitis B immune globulin, in patients having previously undergone liver transplantation.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis B, Chronic
Drug: Specific intravenous anti-hepatitis B immunoglobulin
Monthly doses of 5000 IU administered intravenously during 6 consecutive months
Other Name: Niuliva
Experimental: IGIV-HB Grifols
Intervention: Drug: Specific intravenous anti-hepatitis B immunoglobulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2004
July 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients having undergone a liver transplantation due to liver disease associated with hepatitis B virus, at least 1 year before and no more than 5 years before inclusion in the study.
  2. Patients who have required treatment with HBIG, or are receiving it at present.
  3. Patients from 18 to 70 years of age.
  4. The patient agrees to participate and comply with all aspects of the protocol, including the planned blood sample collection, and has signed the informed consent form.

Exclusion Criteria:

  1. Presence of HBV DNA or HBeAg indicating virus replication.
  2. Patients with known allergies to some component of HB-IVIG, such as sorbitol (e.g. patients presenting intolerance to fructose).
  3. Patients with a known background of severe or frequent reactions to products derived from plasma.
  4. Patients presenting arterial hypertension that is not clinically controlled.
  5. Patients presenting a creatinine value >2 mg/dl, nephrotic syndrome or renal failure.
  6. Patients presenting anaemia (haemoglobin < 11 g/dl).
  7. Patients being treated with interferon.
  8. The patient suffers some acute or chronic medical condition that the investigator believes may interfere with the development or interpretation of the study.
  9. The patient is known to abuse of alcohol, opiates, psychotropic agents or other drugs or chemical substances; or has done so in the past 12 months.
  10. Pregnant women at the time of inclusion or that may be pregnant in the next 7 months or breast-feeding women.
  11. Patients participating in another clinical study, or who have received another investigational product in the last 3 months.
  12. Possibility that the patient may be treated with other products containing immunoglobulins in a period of 7 months.
  13. Suspicion of conditions that may affect the patient's compliance, including an expected survival of less than 1 year.
  14. Any patient that does not have a frozen serum sample previous to the first study medication infusion.
  15. Patients with selective IgA deficiency.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00838071
IG301
No
Antonio Páez, MD, Instituto Grifols
Instituto Grifols, S.A.
Not Provided
Principal Investigator: Antoni Mas, MD Hospital Clínic de Barcelona
Grifols Biologicals Inc.
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP