Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients

This study has been completed.
Sponsor:
Information provided by:
Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00220766
First received: September 13, 2005
Last updated: September 24, 2009
Last verified: September 2009

September 13, 2005
September 24, 2009
August 2002
August 2002   (final data collection date for primary outcome measure)
Infusion related adverse events [ Time Frame: within 72 hours after infusion ] [ Designated as safety issue: Yes ]
  • Wheezing
  • Occuring within 72 hours after infusion:
  • Severe/serious headaches
  • Local vein irritability at infusion vein
  • Fever and or chills
  • Urticaria/hives and or pruritus/itching
  • Nausea and or vomiting/emesis
  • Hypotension
Complete list of historical versions of study NCT00220766 on ClinicalTrials.gov Archive Site
All adverse events [ Time Frame: within 72 hours after infusion ] [ Designated as safety issue: Yes ]
  • All adverse events during and after infusion
  • Vital signs
  • Abnormal laboratory data
  • Adverse events while on placebo (dextrose)
  • Time of daily infusion
Not Provided
Not Provided
 
Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients

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.

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)
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Immunologic Deficiency Syndrome
  • Agammaglobulinemia
  • Severe Combined Immunodeficiency
  • Wiskott-Aldrich Syndrome
  • Common Variable Immunodeficiency
  • Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
    Other Names:
    • Gamunex
    • IGIVnex
    • Gaminex
    • IGIV-C
    • Immune Globulin Intravenous (Human) , 10%
    • IGIV
    • BAY 41-1000
    • TAL-05-00004
  • Drug: Dextrose, 5% in Water
  • Experimental: 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)
    Interventions:
    • Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
    • Drug: Dextrose, 5% in Water
  • Experimental: 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:
    • Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
    • Drug: Dextrose, 5% in Water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2004
August 2002   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00220766
100348
No
Gerald Klein, MD, Chief Medical Officer, Vice President of Medical and Clinical Affairs, Talecris Biotherapeutics, Inc.
Grifols Therapeutics Inc.
Not Provided
Principal Investigator: Erwin Gelfand, MD National Jewish Medical and Research Center, Denver, CO
Grifols Therapeutics Inc.
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP