Agammaglobulinemia, Common Variable Immunodeficiency, Immunologic Deficiency Syndrome, Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome
Conditions
Keywords
Primary Immune Deficiency, IGIV, Immunoglobulin G
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)
Interventions
DRUGDextrose, 5% in Water
Sponsors
Grifols Therapeutics LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infusion related adverse events | within 72 hours after infusion |
Secondary
| Measure | Time frame |
|---|---|
| All adverse events | within 72 hours after infusion |
Countries
Canada, United States
Outcome results
None listed