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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
  Purpose

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 Intervention Phase
Hepatitis B, Chronic
Drug: Specific intravenous anti-hepatitis B immunoglobulin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: October 2003
Study Completion Date: August 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  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: NCT00838071

Locations
Spain
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.
Investigators
Principal Investigator: Antoni Mas, MD Hospital Clínic de Barcelona
  More Information

No publications provided

Responsible Party: Antonio Páez, MD, Instituto Grifols
ClinicalTrials.gov Identifier: NCT00838071     History of Changes
Other Study ID Numbers: IG301
Study First Received: February 5, 2009
Last Updated: February 5, 2009
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on November 24, 2014