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.

Study Overview

• Status: Completed
• Conditions: Common Variable Immunodeficiency; Severe Combined Immunodeficiency; Wiskott-Aldrich Syndrome; Agammaglobulinemia; Immunologic Deficiency Syndrome
• Intervention / Treatment: Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified; Drug: Dextrose, 5% in Water

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)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T8
      • 3031 Hospital Drive Northwest
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3K2
      • St. Paul's Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
    • Toronto, Ontario, Canada, M4V 1R2
      • Saint Michael's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Departments of Medicine and Microbiology
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Medical and Researach Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • International Center for Interdisciplinary Studies of Immunology
  • Florida
    • North Palm Beach, Florida, United States, 33408
      • Allergy Associates of the Palm Beaches
    • St. Petersburg, Florida, United States, 33701
      • University of South Florida College of Medicine
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • The Clinical Trials Center, Children's Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Allergy, Asthma, and Immunology
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
    • Columbus, Ohio, United States, 43235
      • Optimed Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified; Other Names: Gamunex; Gaminex; IGIV-C; Immune Globulin Intravenous (Human) , 10%; IGIV; BAY 41-1000; TAL-05-00004; IGIVnex; 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)	Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified; Other Names: Gamunex; Gaminex; IGIV-C; Immune Globulin Intravenous (Human) , 10%; IGIV; BAY 41-1000; TAL-05-00004; IGIVnex; Drug: Dextrose, 5% in Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Infusion related adverse events	within 72 hours after infusion

Secondary Outcome Measures

Outcome Measure	Time Frame
All adverse events	within 72 hours after infusion

Collaborators and Investigators

• Sponsor: Grifols Therapeutics LLC
• Investigators: Principal Investigator: Erwin Gelfand, MD, National Jewish Medical and Research Center, Denver, CO

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Primary Completion (Actual): August 1, 2002
• Study Completion (Actual): March 1, 2004

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): September 25, 2009
• Last Update Submitted That Met QC Criteria: September 24, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Immunoglobulin G; Primary Immune Deficiency; IGIV
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Disease; Hematologic Diseases; Infant, Newborn, Diseases; Blood Coagulation Disorders, Inherited; Hemorrhagic Disorders; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Blood Protein Disorders; Blood Coagulation Disorders; DNA Repair-Deficiency Disorders; Leukopenia; Leukocyte Disorders; Primary Immunodeficiency Diseases; Lymphopenia; Syndrome; Immunologic Deficiency Syndromes; Severe Combined Immunodeficiency; Wiskott-Aldrich Syndrome; Agammaglobulinemia; Common Variable Immunodeficiency; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin; Immunoglobulin G
• Other Study ID Numbers: 100348