Study Results
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Basic Information
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COMPLETED
PHASE3
57 participants
INTERVENTIONAL
2006-11-30
2009-08-31
Brief Summary
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Detailed Description
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Approximately 50 subjects will be enrolled for 16 Months:
screening- 1 month treatment-12 months follow-up-3 months
Subjects will be infused every 21 to 28 days according to their previous IVIG treatment schedule. Subjects treated every 28 days will receive 13 study IGIV infusions. Subjects treated every 21 days will receive 17 study IGIV infusions.
We will record the incidence of acute infections, especially acute serious bacterial infections, during the year each subjet is on study.
We will record the incidence of adverse events that occur during each infusion and up to 48 hours after each infusion.
At the time the study is explained to the subjects, each investigator will ask all subjects whose body weight is above 37 kg (or greater as defined by local standards) about their willingness to participate in the pharmacokinetic (PK) portion of the study. This will involve 4 additional visits after the 5th or 6th study IGIV infusion in order to draw blood samples for analysis.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Intravenous Immune Globulin
Subjects with primary humoral immunodeficiency
Immune Globulin Intravenous (Human) Omr-IgG-am IGIV
IGIV infusions of 300-900 mg/kg every 3 or 4 weeks
Interventions
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Immune Globulin Intravenous (Human) Omr-IgG-am IGIV
IGIV infusions of 300-900 mg/kg every 3 or 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Confirmed clinical diagnosis of a Primary Immune Deficiency disease including hypogammaglobulinemia, preferably with documented antibody deficiency, or agammaglobulinemia.
* Has been receiving licensed IGIV for at least 3 months prior to this study.
* Trough IgG levels, dose of IGIV, and treatment intervals for the last 2 consecutive licensed IGIV treatments must be documented.
* The subject or legal guardian has signed the informed consent form. If appropriate, the subject has signed a child assent form.
* The subject or legal representative has signed the HIPAA declaration.
Exclusion Criteria
* The subject has a history of hypersensitivity or persistent or repeated adverse reactions to human immunoglobulin.
* The subject has selective IgA deficiency, history of reaction to products containing IgA, or is known to have antibodies to IgA.
* The subject is currently participating, or has participated within the previous 30 days, in another clinical study of an investigational product or device.
* The subject is pregnant or is nursing. Women of childbearing potential must agree to using a method of contraception.
* The subject has had an acute bacterial infection within 28 days of screening.
* The subject is seropositive for any of the following at screening:
* Antibodies to HIV 1\&2
* Antibodies to HCV
* HbsAg
* The subject, at screening, has alanine aminotransferase (ALT) levels greater than 2.5 times the upper limit of normal.
* The subject has severe renal impairment.
* The subject has a history of DVT, thrombotic or thrombic complications of IGIV therapy.
* The subject suffers from any acute or chronic medical condition that, in the opinion of the investigator, may interfere with the conduct of the study.
* The subject has an acquired medical condition known to cause secondary immune deficiency or otherwise increase the subject's risk of infection.
3 Years
75 Years
ALL
No
Sponsors
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OMRIX Biopharmaceuticals
INDUSTRY
FFF Enterprises
INDUSTRY
Responsible Party
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Principal Investigators
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Chaim Roifman, MD
Role: STUDY_CHAIR
The Hospital for Sick Children
Robert Roberts, MD
Role: PRINCIPAL_INVESTIGATOR
Mattel Children's Hospital of UCLA
Isaac R Melamed, MD
Role: PRINCIPAL_INVESTIGATOR
1st Allergey and Clinical Research Center
James Moy, MD
Role: PRINCIPAL_INVESTIGATOR
Rush Universitity Medical Centre
Eyal Grunebaum, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Gordan L Sussman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Akhilesh Chouksey, MD
Role: PRINCIPAL_INVESTIGATOR
Rainbow Babies and Children's Hospital
Mark Stein, MD
Role: PRINCIPAL_INVESTIGATOR
Allergy Associates of the Palm Beaches
Richard L Wasserman, MD
Role: PRINCIPAL_INVESTIGATOR
Daniel Suez, MD
Role: PRINCIPAL_INVESTIGATOR
Allergy, Asthma and Immunology Clinic PA
Don McNeil, MD
Role: PRINCIPAL_INVESTIGATOR
Optimed Research LLC
Locations
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Mattel Children's Hospital of UCLA
Los Angeles, California, United States
1st Allergy and Clinical Research Center
Centennial, Colorado, United States
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Optimed Research, LLC
Columbus, Ohio, United States
Pediatric Allergy Immunology Associates
Dallas, Texas, United States
Allergy, Asthma and Immunology Clinic PA
Irving, Texas, United States
University of Toronto
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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Ten RM. Primary immunodeficiencies. Mayo Clin Proc. 1998 Sep;73(9):865-72. doi: 10.4065/73.9.865.
Bonilla FA, Geha RS. 12. Primary immunodeficiency diseases. J Allergy Clin Immunol. 2003 Feb;111(2 Suppl):S571-81. doi: 10.1067/mai.2003.86.
Bonilla FA, Bernstein IL, Khan DA, Ballas ZK, Chinen J, Frank MM, Kobrynski LJ, Levinson AI, Mazer B, Nelson RP Jr, Orange JS, Routes JM, Shearer WT, Sorensen RU; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol. 2005 May;94(5 Suppl 1):S1-63. doi: 10.1016/s1081-1206(10)61142-8. No abstract available.
Chapel HM. Consensus on diagnosis and management of primary antibody deficiencies. Consensus Panel for the Diagnosis and Management of Primary Antibody Deficiencies. BMJ. 1994 Feb 26;308(6928):581-5. doi: 10.1136/bmj.308.6928.581. No abstract available.
Roifman CM, Levison H, Gelfand EW. High-dose versus low-dose intravenous immunoglobulin in hypogammaglobulinaemia and chronic lung disease. Lancet. 1987 May 9;1(8541):1075-7. doi: 10.1016/s0140-6736(87)90494-6.
Eijkhout HW, van Der Meer JW, Kallenberg CG, Weening RS, van Dissel JT, Sanders LA, Strengers PF, Nienhuis H, Schellekens PT; Inter-University Working Party for the Study of Immune Deficiencies. The effect of two different dosages of intravenous immunoglobulin on the incidence of recurrent infections in patients with primary hypogammaglobulinemia. A randomized, double-blind, multicenter crossover trial. Ann Intern Med. 2001 Aug 7;135(3):165-74. doi: 10.7326/0003-4819-135-3-200108070-00008.
Roifman CM, Schroeder H, Berger M, Sorensen R, Ballow M, Buckley RH, Gewurz A, Korenblat P, Sussman G, Lemm G. Comparison of the efficacy of IGIV-C, 10% (caprylate/chromatography) and IGIV-SD, 10% as replacement therapy in primary immune deficiency. A randomized double-blind trial. Int Immunopharmacol. 2003 Sep;3(9):1325-33. doi: 10.1016/s1567-5769(03)00134-6.
Berger M. A history of immune globulin therapy, from the Harvard crash program to monoclonal antibodies. Curr Allergy Asthma Rep. 2002 Sep;2(5):368-78. doi: 10.1007/s11882-002-0069-z.
Other Identifiers
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NCT00468273
Identifier Type: REGISTRY
Identifier Source: secondary_id
GAM-PID-03-US
Identifier Type: -
Identifier Source: org_study_id
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