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

Common Variable Immunodeficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220766
• Other study ID #: 100348
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 24, 2009
• Start date: August 2002
• Est. completion date: March 2004

Study information

• Verified date: September 2009
• Source: Grifols Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2004
• Est. primary completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

• Dextrose, 5% in Water

Locations

Country	Name	City	State
Canada	3031 Hospital Drive Northwest	Calgary	Alberta
Canada	Saint Michael's Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
United States	Departments of Medicine and Microbiology	Birmingham	Alabama
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Optimed Research, LLC	Columbus	Ohio
United States	National Jewish Medical and Researach Center	Denver	Colorado
United States	The Clinical Trials Center, Children's Hospital	New Orleans	Louisiana
United States	Allergy Associates of the Palm Beaches	North Palm Beach	Florida
United States	Allergy, Asthma, and Immunology	Omaha	Nebraska
United States	University of South Florida College of Medicine	St. Petersburg	Florida
United States	International Center for Interdisciplinary Studies of Immunology	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Grifols Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infusion related adverse events		within 72 hours after infusion	Yes
Secondary	All adverse events		within 72 hours after infusion	Yes