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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00838071
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : February 6, 2009
Information provided by:
Grifols Biologicals Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Specific intravenous anti-hepatitis B immunoglobulin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : October 2003
Actual Primary Completion Date : July 2004
Actual Study Completion Date : August 2004

Arm Intervention/treatment
Experimental: IGIV-HB Grifols Drug: Specific intravenous anti-hepatitis B immunoglobulin
Monthly doses of 5000 IU administered intravenously during 6 consecutive months
Other Name: Niuliva

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To determine various pharmacokinetic parameters after 6 administrations of HB-IVIG Grifols [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ]
  3. To determine the incidence of recurrences during the treatment [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ]
  4. To evaluate tolerance to the administration of HB-IVIG Grifols [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ]
  5. To confirm the viral safety of the product supervising viral markers [ Time Frame: At months 1, 2, 3, 4, 5, and 6 ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00838071

Hospital Clínic de Barcelona
Barcelona, Spain, 08035
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Sponsors and Collaborators
Instituto Grifols, S.A.
Principal Investigator: Antoni Mas, MD Hospital Clínic de Barcelona

Responsible Party: Antonio Páez, MD, Instituto Grifols Identifier: NCT00838071     History of Changes
Other Study ID Numbers: IG301
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
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
Hepatitis, Chronic
Hepatitis B Antibodies
Immunologic Factors
Physiological Effects of Drugs