Clinical trial NCT00220766: Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
Official title: IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immunologic Deficiency Syndrome
Agammaglobulinemia
Severe Combined Immunodeficiency
Wiskott-Aldrich Syndrome
Common Variable Immunodeficiency
Keywords: Primary Immune Deficiency
IGIV
Immunoglobulin G
Lead sponsor: Grifols Therapeutics LLC
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: Infusion related adverse events
timeFrame: within 72 hours after infusion
Secondary outcomes:
measure: All adverse events
timeFrame: within 72 hours after infusion
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Departments of Medicine and Microbiology
state: Alabama
city: Denver
country: United States
facility: National Jewish Medical and Researach Center
state: Colorado
city: Washington
country: United States
facility: International Center for Interdisciplinary Studies of Immunology
state: District of Columbia
city: North Palm Beach
country: United States
facility: Allergy Associates of the Palm Beaches
state: Florida
city: St. Petersburg
country: United States
facility: University of South Florida College of Medicine
state: Florida
city: New Orleans
country: United States
facility: The Clinical Trials Center, Children's Hospital
state: Louisiana
city: Omaha
country: United States
facility: Allergy, Asthma, and Immunology
state: Nebraska
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Optimed Research, LLC
state: Ohio
city: Calgary
country: Canada
facility: 3031 Hospital Drive Northwest
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Saint Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: National Jewish Medical and Research Center, Denver, CO
name: Erwin Gelfand, MD
role: PRINCIPAL_INVESTIGATOR
References: