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

NCT ID: NCT00220766

Last Updated: 2009-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2004-03-31

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)

Conditions

Immunologic Deficiency Syndrome; Agammaglobulinemia; Severe Combined Immunodeficiency; Wiskott-Aldrich Syndrome; Common Variable Immunodeficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 Type: EXPERIMENTAL

Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified

Intervention Type: DRUG

Dextrose, 5% in Water

Intervention Type: DRUG

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)

Group Type: EXPERIMENTAL

Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified

Intervention Type: DRUG

Dextrose, 5% in Water

Intervention Type: DRUG

Interventions

Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified

Intervention Type: DRUG

Dextrose, 5% in Water

Intervention Type: DRUG

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grifols Therapeutics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Talecris Biotherapeutics, Inc.

Principal Investigators

Erwin Gelfand, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Medical and Research Center, Denver, CO

Locations

Departments of Medicine and Microbiology

Birmingham, Alabama, United States

National Jewish Medical and Researach Center

Denver, Colorado, United States

International Center for Interdisciplinary Studies of Immunology

Washington D.C., District of Columbia, United States

Allergy Associates of the Palm Beaches

North Palm Beach, Florida, United States

University of South Florida College of Medicine

St. Petersburg, Florida, United States

The Clinical Trials Center, Children's Hospital

New Orleans, Louisiana, United States

Allergy, Asthma, and Immunology

Omaha, Nebraska, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

Optimed Research, LLC

Columbus, Ohio, United States

3031 Hospital Drive Northwest

Calgary, Alberta, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

Saint Michael's Hospital

Toronto, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

100348

Identifier Type: -

Identifier Source: org_study_id