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

Information source: Talecris Biotherapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Immunologic Deficiency Syndrome; Agammaglobulinemia; Severe Combined Immunodeficiency; Wiskott-Aldrich Syndrome; Common Variable Immunodeficiency

Intervention: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified (Drug); Dextrose, 5% in Water (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Talecris Biotherapeutics

Official(s) and/or principal investigator(s):
Erwin Gelfand, MD, Principal Investigator, Affiliation: National Jewish Medical and Research Center, Denver, CO

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.

Clinical Details

Official title: IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients

Study design: Treatment, Randomized, Single Blind (Subject), Dose Comparison, Crossover Assignment, Safety Study

Primary outcome: Infusion related adverse events

Secondary outcome: All adverse events

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Departments of Medicine and Microbiology, Birmingham, Alabama 35294, United States

3031 Hospital Drive Northwest, Calgary, Alberta T2N 2T8, Canada

St. Paul's Hospital, Vancouver, British Columbia V6H 3K2, Canada

National Jewish Medical and Researach Center, Denver, Colorado 80206, United States

International Center for Interdisciplinary Studies of Immunology, Washington, District of Columbia 20007, United States

University of South Florida College of Medicine, St. Petersburg, Florida 33701, United States

Allergy Associates of the Palm Beaches, North Palm Beach, Florida 33408, United States

The Clinical Trials Center, Children's Hospital, New Orleans, Louisiana 70118, United States

Allergy, Asthma, and Immunology, Omaha, Nebraska 68124, United States

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States

Optimed Research, LLC, Columbus, Ohio 43235, United States

The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada

Saint Michael's Hospital, Toronto, Ontario M4V 1R2, Canada

Additional Information

Starting date: August 2002
Ending date: March 2004
Last updated: September 27, 2007

Page last updated: June 20, 2008

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