Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients - Full Text View

Sponsor:	Talecris Biotherapeutics
Information provided by:	Talecris Biotherapeutics
ClinicalTrials.gov Identifier:	NCT00220766

Purpose

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.

Condition	Intervention	Phase
Immunologic Deficiency Syndrome Agammaglobulinemia Severe Combined Immunodeficiency Wiskott-Aldrich Syndrome Common Variable Immunodeficiency	Drug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified Drug: Dextrose, 5% in Water	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia adenosine deaminase deficiency common variable immune deficiency complement factor I deficiency hemophilia Wiskott-Aldrich syndrome X-linked agammaglobulinemia X-linked severe combined immunodeficiency ZAP70-related severe combined immunodeficiency Help Me Understand Genetics

Drug Information available for: Dextrose Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Talecris Biotherapeutics:

Primary Outcome Measures:

Infusion related adverse events [ Time Frame: within 72 hours after infusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

All adverse events [ Time Frame: within 72 hours after infusion ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	August 2002
Study Completion Date:	March 2004
Primary Completion Date:	August 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 IGIVnex Gaminex IGIV-C Immune Globulin Intravenous (Human) , 10% IGIV BAY 41-1000 TAL-05-00004 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 IGIVnex Gaminex IGIV-C Immune Globulin Intravenous (Human) , 10% IGIV BAY 41-1000 TAL-05-00004 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)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220766

Locations

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

Sponsors and Collaborators

Talecris Biotherapeutics

Investigators

Principal Investigator:

Erwin Gelfand, MD

National Jewish Medical and Research Center, Denver, CO

More Information

No publications provided

Responsible Party:	Gerald Klein, MD, Chief Medical Officer, Vice President of Medical and Clinical Affairs, Talecris Biotherapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00220766 History of Changes
Other Study ID Numbers:	100348
Study First Received:	September 13, 2005
Last Updated:	September 24, 2009
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Talecris Biotherapeutics:

Primary Immune Deficiency
IGIV
Immunoglobulin G

Additional relevant MeSH terms:

Agammaglobulinemia
Common Variable Immunodeficiency
Immunologic Deficiency Syndromes
Wiskott-Aldrich Syndrome
Severe Combined Immunodeficiency
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immune System Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hemorrhagic Disorders
Lymphopenia

Leukopenia
Leukocyte Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Infant, Newborn, Diseases
DNA Repair-Deficiency Disorders
Metabolic Diseases
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012