Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
- Conditions
- Immunologic Deficiency SyndromeAgammaglobulinemiaSevere Combined ImmunodeficiencyWiskott-Aldrich SyndromeCommon Variable Immunodeficiency
- Interventions
- Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography PurifiedDrug: Dextrose, 5% in Water
- Registration Number
- NCT00220766
- Lead Sponsor
- Grifols Therapeutics LLC
- 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.
- 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 treated with two daily infusions given 3-4 weeks apart at the fixed individual IGIV dose regimen (400-600 mg/kg) established prior to entry into the study. Any subject with an established dose in the range of 200-399 mg/kg will be assigned to receive 400 mg/kg during the course of the study during the same dosing schedule established prior to entry into the study.
After a screening period lasting not more than four weeks, patients will be randomized into one of two cross-over groups. Patients randomized to Group 1 will receive their first IGIV-C, 10% dose at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min, whereas patients randomized to Group 2 will receive IGIV-C, 10% at a rate of 0.14 mL/kg/min on the first infusion day and then 0.08 mL/kg/min on the second infusion day. All patients just prior to each IGIV-C, 10% infusion will receive the same volume of 5% dextrose as calculated for their IGIV-C, 10% infusion and given at a target rate according to the schema below.
Group 1:
* Infusion #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:
* Infusion #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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 1 Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified Infusion #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 1 Dextrose, 5% in Water Infusion #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 Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified Infusion #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) Group 2 Dextrose, 5% in Water Infusion #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)
- Primary Outcome Measures
Name Time Method Infusion related adverse events within 72 hours after infusion
- Secondary Outcome Measures
Name Time Method All adverse events within 72 hours after infusion
Trial Locations
- Locations (13)
The Clinical Trials Center, Children's Hospital
🇺🇸New Orleans, Louisiana, United States
National Jewish Medical and Researach Center
🇺🇸Denver, Colorado, United States
International Center for Interdisciplinary Studies of Immunology
🇺🇸Washington, District of Columbia, United States
University of South Florida College of Medicine
🇺🇸St. Petersburg, Florida, United States
Departments of Medicine and Microbiology
🇺🇸Birmingham, Alabama, United States
Allergy Associates of the Palm Beaches
🇺🇸North Palm Beach, Florida, United States
Allergy, Asthma, and Immunology
🇺🇸Omaha, Nebraska, United States
Optimed Research, LLC
🇺🇸Columbus, Ohio, United States
3031 Hospital Drive Northwest
🇨🇦Calgary, Alberta, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Saint Michael's Hospital
🇨🇦Toronto, Ontario, Canada
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States