Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
This study has been completed.
Sponsor:
Grifols Therapeutics Inc.
Information provided by:
Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00220766
First received: September 13, 2005
Last updated: September 24, 2009
Last verified: September 2009
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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 3 |
| 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:
adenosine deaminase deficiency
common variable immune deficiency
complement factor I deficiency
purine nucleoside phosphorylase deficiency
Wiskott-Aldrich syndrome
X-linked severe combined immunodeficiency
ZAP70-related severe combined immunodeficiency
U.S. FDA Resources
Further study details as provided by Grifols Therapeutics Inc.:
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:
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:
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
Grifols Therapeutics Inc.
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 Grifols Therapeutics Inc.:
|
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 May 23, 2013