Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients

Completed · Phase 3

Conditions studied: Immunologic Deficiency Syndrome, Agammaglobulinemia, Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome, Common Variable Immunodeficiency

In brief

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 different infusion rates. The primary objective is to compare the incidence and severity of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14 mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.

Key facts

Study ID

NCT00220766

Run by

Grifols Therapeutics LLC

People needed

100

Starts

2002-08-01

Expected to finish

2004-03-01

Last updated by the study team

2009-09-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Departments of Medicine and Microbiology — Birmingham, Alabama, United States
• National Jewish Medical and Researach Center — Denver, Colorado, United States
• International Center for Interdisciplinary Studies of Immunology — Washington D.C., District of Columbia, United States
• Allergy Associates of the Palm Beaches — North Palm Beach, Florida, United States
• University of South Florida College of Medicine — St. Petersburg, Florida, United States
• The Clinical Trials Center, Children's Hospital — New Orleans, Louisiana, United States
• Allergy, Asthma, and Immunology — Omaha, Nebraska, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Optimed Research, LLC — Columbus, Ohio, United States
• 3031 Hospital Drive Northwest — Calgary, Alberta, Canada
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• Saint Michael's Hospital — Toronto, Ontario, Canada
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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