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

Primary Purpose

Immunologic Deficiency Syndrome, Agammaglobulinemia, Severe Combined Immunodeficiency

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
Dextrose, 5% in Water
Sponsored by
Grifols Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immunologic Deficiency Syndrome focused on measuring Primary Immune Deficiency, IGIV, Immunoglobulin G

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Departments of Medicine and Microbiology
  • National Jewish Medical and Researach Center
  • International Center for Interdisciplinary Studies of Immunology
  • Allergy Associates of the Palm Beaches
  • University of South Florida College of Medicine
  • The Clinical Trials Center, Children's Hospital
  • Allergy, Asthma, and Immunology
  • University Hospitals of Cleveland
  • Optimed Research, LLC
  • 3031 Hospital Drive Northwest
  • St. Paul's Hospital
  • Saint Michael's Hospital
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Infusion related adverse events

Secondary Outcome Measures

All adverse events

Full Information

First Posted
September 13, 2005
Last Updated
September 24, 2009
Sponsor
Grifols Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00220766
Brief Title
Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
Official Title
IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Grifols Therapeutics LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunologic Deficiency Syndrome, Agammaglobulinemia, Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome, Common Variable Immunodeficiency
Keywords
Primary Immune Deficiency, IGIV, Immunoglobulin G

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
Other Intervention Name(s)
Gamunex, IGIVnex, Gaminex, IGIV-C, Immune Globulin Intravenous (Human) , 10%, IGIV, BAY 41-1000, TAL-05-00004
Intervention Type
Drug
Intervention Name(s)
Dextrose, 5% in Water
Primary Outcome Measure Information:
Title
Infusion related adverse events
Time Frame
within 72 hours after infusion
Secondary Outcome Measure Information:
Title
All adverse events
Time Frame
within 72 hours after infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erwin Gelfand, MD
Organizational Affiliation
National Jewish Medical and Research Center, Denver, CO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departments of Medicine and Microbiology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
National Jewish Medical and Researach Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
International Center for Interdisciplinary Studies of Immunology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Allergy Associates of the Palm Beaches
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
University of South Florida College of Medicine
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
The Clinical Trials Center, Children's Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Allergy, Asthma, and Immunology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Optimed Research, LLC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
3031 Hospital Drive Northwest
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T8
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3K2
Country
Canada
Facility Name
Saint Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1R2
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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

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