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Study 16 of 17 for search of: | "Agammaglobulinemia" |
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Sponsored by: |
FFF Enterprises |
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Information provided by: | FFF Enterprises |
ClinicalTrials.gov Identifier: | NCT00468273 |
The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human) [IGIV], 5% Solution Omr-IgG-am™ in patients with primary immunodeficiency diseases.
Condition | Intervention | Phase |
---|---|---|
Immunologic Deficiency Syndromes |
Drug: Omr-IgG-am |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Clinical Study of the Pharmacokinetics, Efficacy and Safety of Immune Globulin Intravenous (Human) Omr-IgG-am IGIV in Subjects With Primary Immune Deficiency Diseases |
Estimated Enrollment: | 50 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | October 2008 |
This is an open label, single-arm, prospective, multi-center, uncontrolled Phase III clinical study to evaluate the efficacy, pharmacokinetics and safety of Omr-IgG-am™ in patients with primary immunodificiency diseases.
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 actute 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.
Ages Eligible for Study: | 3 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
The following list is incomplete. A complete list is in the protocol.
Inclusion Criteria:
Exclusion Criteria:
Contact: Philip A Sinclair, PhD | 613-228-1990 ext 114 | psinclair@allphaseclilnical.com |
Contact: John A Hooper, PhD | 816-792-0423 | johnhooper@kc.rr.com |
United States, California | |
Mattel Children's Hospital of UCLA | Recruiting |
Los Angeles, California, United States, 90095-1752 | |
Contact: Sherry Jeffery 310-794-2587 sjeffery@mednet.ucla.edu | |
Principal Investigator: Robert Roberts, MD | |
United States, Colorado | |
1st Allergy and Clinical Research Center | Recruiting |
Centennial, Colorado, United States, 80112 | |
Contact: Melissa Stevenson 303-224-4665 | |
Principal Investigator: Isaac R Melamed, MD | |
United States, Florida | |
Allergy Associates of the Palm Beaches | Recruiting |
North Palm Beach, Florida, United States, 33408 | |
Contact: Kelly Farnan 561-626-4561 | |
Principal Investigator: Mark Stein, MD | |
United States, Illinois | |
Rush University Medical Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Tom Tyler 312-942-6352 | |
Principal Investigator: James Moy, MD | |
United States, Ohio | |
Rainbow Babies and Children's Hospital | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Eloise Lemon 216-844-3681 | |
Principal Investigator: Akhilesh Chouksey, MD | |
Optimed Research, LLC | Recruiting |
Columbus, Ohio, United States, 43235 | |
Contact: Sonia Alcott 614-430-8022 ext 108 | |
Principal Investigator: Don McNeil, MD | |
United States, Texas | |
Pediatric Allergy Immunology Associates | Recruiting |
Dallas, Texas, United States, 75230 | |
Contact: Carrie Miller 972-566-5473 | |
Principal Investigator: Richard L Wasserman, MD | |
Allergy, Asthma and Immunology Clinic PA | Recruiting |
Irving, Texas, United States, 75230 | |
Contact: Kristi Gasset 972-401-0545 | |
Principal Investigator: Daniel Suez, MD | |
Canada, Ontario | |
The Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada, M5G1X8 | |
Contact: Brenda Reid 416-813-5301 | |
Principal Investigator: Eyal Grunebaum, MD | |
University of Toronto | Recruiting |
Toronto, Ontario, Canada, M4V1R2 | |
Contact: Loris Aro 416-458-7473 | |
Principal Investigator: Gordon L Sussman, MD |
Study Chair: | Chaim Roifman, MD | The Hospital for Sick Children |
Principal Investigator: | Robert Roberts, MD | Mattel Children's Hospital of UCLA |
Principal Investigator: | Isaac R Melamed, MD | 1st Allergey and Clinical Research Center |
Principal Investigator: | James Moy, MD | Rush Universitity Medical Centre |
Principal Investigator: | Eyal Grunebaum, MD | The Hospital for Sick Children |
Principal Investigator: | Gordan L Sussman, MD | University of Toronto |
Principal Investigator: | Akhilesh Chouksey, MD | Rainbow Babies and Children's Hospital |
Principal Investigator: | Mark Stein, MD | Allergy Associates of the Palm Beaches |
Principal Investigator: | Richard L Wasserman, MD | Unaffiliated |
Principal Investigator: | Daniel Suez, MD | Allergy, Asthma and Immunology Clinic PA |
Principal Investigator: | Don McNeil, MD | Optimed Research LLC |
Study ID Numbers: | GAM-PID-03-US |
Study First Received: | May 1, 2007 |
Last Updated: | May 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00468273 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Deficiency Syndromes, Antibody Antibody Deficiency Syndrome Bruton's agammaglobulinemia Common Variable Immune Deficiency Hyper IgM syndromes |
Agammaglobulinemia Hyper-IgM Immunodeficiency Syndrome, Type 1 Bruton type agammaglobulinemia Immunologic Deficiency Syndromes Antibodies Malnutrition Hyper IgM syndrome |
X-linked agammaglobulinemia Hyperkinesis Nutrition Disorders Hyper-IgM Immunodeficiency Syndrome Deficiency Diseases Immunoglobulins |
Pathologic Processes Disease Immune System Diseases Syndrome |