Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients
1 other identifier
interventional
100
2 countries
13
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2002
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedSeptember 25, 2009
September 1, 2009
Same day
September 13, 2005
September 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infusion related adverse events
within 72 hours after infusion
Secondary Outcomes (1)
All adverse events
within 72 hours after infusion
Study Arms (2)
Group 1
EXPERIMENTALInfusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min) ; Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)
Group 2
EXPERIMENTALInfusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min); Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Departments of Medicine and Microbiology
Birmingham, Alabama, 35294, United States
National Jewish Medical and Researach Center
Denver, Colorado, 80206, United States
International Center for Interdisciplinary Studies of Immunology
Washington D.C., District of Columbia, 20007, United States
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, 33408, United States
University of South Florida College of Medicine
St. Petersburg, Florida, 33701, United States
The Clinical Trials Center, Children's Hospital
New Orleans, Louisiana, 70118, United States
Allergy, Asthma, and Immunology
Omaha, Nebraska, 68124, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Optimed Research, LLC
Columbus, Ohio, 43235, United States
3031 Hospital Drive Northwest
Calgary, Alberta, T2N 2T8, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6H 3K2, Canada
Saint Michael's Hospital
Toronto, Ontario, M4V 1R2, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erwin Gelfand, MD
National Jewish Medical and Research Center, Denver, CO
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
August 1, 2002
Primary Completion
August 1, 2002
Study Completion
March 1, 2004
Last Updated
September 25, 2009
Record last verified: 2009-09