Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
Information source: Grifols Therapeutics Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Immunologic Deficiency Syndrome; Agammaglobulinemia; Severe Combined Immunodeficiency; Wiskott-Aldrich Syndrome; Common Variable Immunodeficiency
Intervention: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified (Drug); Dextrose, 5% in Water (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Grifols Therapeutics Inc. Official(s) and/or principal investigator(s): Erwin Gelfand, MD, Principal Investigator, Affiliation: National Jewish Medical and Research Center, Denver, CO
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.
Clinical Details
Official title: IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Infusion related adverse events
Secondary outcome: All adverse events
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)
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Departments of Medicine and Microbiology, Birmingham, Alabama 35294, United States
3031 Hospital Drive Northwest, Calgary, Alberta T2N 2T8, Canada
St. Paul's Hospital, Vancouver, British Columbia V6H 3K2, Canada
National Jewish Medical and Researach Center, Denver, Colorado 80206, United States
International Center for Interdisciplinary Studies of Immunology, Washington, 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
Saint Michael's Hospital, Toronto, Ontario M4V 1R2, Canada
The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada
Additional Information
Starting date: August 2002
Last updated: September 24, 2009
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