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

Sponsor

Grifols Therapeutics LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00220766

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

7.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	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

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)

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2002

Actual Primary Completion Date :

Aug 1, 2002

Actual Study Completion Date :

Mar 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
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: Gamunex IGIVnex Gaminex IGIV-C Immune Globulin Intravenous (Human) , 10% IGIV BAY 41-1000 TAL-05-00004 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: Gamunex IGIVnex Gaminex IGIV-C Immune Globulin Intravenous (Human) , 10% IGIV BAY 41-1000 TAL-05-00004 Drug: Dextrose, 5% in Water

Arm

Intervention/Treatment

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:

Gamunex

IGIVnex

Gaminex

IGIV-C

Immune Globulin Intravenous (Human) , 10%

IGIV

BAY 41-1000

TAL-05-00004

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:

Gamunex

IGIVnex

Gaminex

IGIV-C

Immune Globulin Intravenous (Human) , 10%

IGIV

BAY 41-1000

TAL-05-00004

Drug: Dextrose, 5% in Water

Outcome Measures

Primary Outcome Measures

Infusion related adverse events [within 72 hours after infusion]

Secondary Outcome Measures

All adverse events [within 72 hours after infusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Departments of Medicine and Microbiology	Birmingham	Alabama	United States	35294
2	National Jewish Medical and Researach Center	Denver	Colorado	United States	80206
3	International Center for Interdisciplinary Studies of Immunology	Washington	District of Columbia	United States	20007
4	Allergy Associates of the Palm Beaches	North Palm Beach	Florida	United States	33408
5	University of South Florida College of Medicine	St. Petersburg	Florida	United States	33701
6	The Clinical Trials Center, Children's Hospital	New Orleans	Louisiana	United States	70118
7	Allergy, Asthma, and Immunology	Omaha	Nebraska	United States	68124
8	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
9	Optimed Research, LLC	Columbus	Ohio	United States	43235
10	3031 Hospital Drive Northwest	Calgary	Alberta	Canada	T2N 2T8
11	St. Paul's Hospital	Vancouver	British Columbia	Canada	V6H 3K2
12	Saint Michael's Hospital	Toronto	Ontario	Canada	M4V 1R2
13	The Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8