Status:
COMPLETED
Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
Lead Sponsor:
Grifols Therapeutics LLC
Conditions:
Immunologic Deficiency Syndrome
Agammaglobulinemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two differen...
Detailed Description
This is a prospective, single blind, randomized, multi-center cross-over trial in patients with Primary Immune Deficiency. Patients with a confirmed diagnosis of primary Immune Deficiency will be trea...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of primary immune deficiency and medical records available for retrospective review for at least 3 months prior to entry into the trial
- Signed an informed consent written informed consent prior to initiation of any study related procedures
- Receiving regular infusions of IGIV at a fixed interval and dosage (in the range of 200-600 mg/kg given every 3-4 weeks) for at least three months prior to entry into the trial. Patients who are currently receiving less than 400 mg/kg are eligible for this trial and will be at the time of study enrollment be treated at 400 mg/kg
Exclusion
- History or suspicion of significant allergic reaction to intravenous immune globulin, and/or blood products
- Documented history of selective IgA deficiency (serum level \<5.0 mg/dL) and known antibodies to IgA
- Isolated IgG subclass deficiency with a normal total serum IgG level
- Other conditions which may interfere with the trial, include the patients demeanor or mental ability to follow instruction.
- Pretreatment with anti-pyretics or anti-histamines
- Congestive heart failure (New York Heart Association stage greater than Class II)
- Renal insufficiency (creatinine \>2.5 mg/dL)
- Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
- Pretreatment routinely required to control/ameliorate IGIV infusion-related adverse events (AEs)
- Any patient who requires IGIV dosing more frequently than every 3 weeks to maintain adequate trough levels
- Women of child bearing potential who do not practice adequate contraception (i.e. chemical or mechanical methods) and pregnant or lactating females
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00220766
Start Date
August 1 2002
End Date
March 1 2004
Last Update
September 25 2009
Active Locations (13)
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1
Departments of Medicine and Microbiology
Birmingham, Alabama, United States, 35294
2
National Jewish Medical and Researach Center
Denver, Colorado, United States, 80206
3
International Center for Interdisciplinary Studies of Immunology
Washington D.C., District of Columbia, United States, 20007
4
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, United States, 33408