Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

Common Variable Immunodeficiency Clinical Trial

Official title:

A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322556
• Other study ID #: ZLB05_006CR
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2006
• Last updated: September 27, 2012
• Start date: November 2005
• Est. completion date: April 2008

Study information

• Verified date: September 2012
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 71 Years

Eligibility

Key Inclusion Criteria:

Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia) who:

Participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03_002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)

OR

Were = 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were interested in participating in the Phase III clinical study with subcutaneous IgPro20 (study number ZLB04_009CR) (referred to as 'new' subjects)

Written informed consent

Key Exclusion Criteria:

Diagnosis of epilepsia

Insulin dependent diabetes

Administration of steroids (daily = 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs

History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Agammaglobulinemia
• Common Variable Immunodeficiency
• IgG Deficiency
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Immunoglobulins Intravenous (Human)
Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw

Locations

Country	Name	City	State
United States	Contact CSL Behring for facility details	Centennial	Colorado
United States	Contact CSL Behring for facility details	Dallas	Texas
United States	Contact CSL Behring for facility details	Fort Wayne	Indiana
United States	Contact CSL Behring for facility details	Indianapolis	Indiana
United States	Contact CSL Behring for facility details	Iowa City	Iowa
United States	Contact CSL Behring for facility details	Los Angeles	California
United States	Contact CSL Behring for facility details	North Palm Beach	Florida
United States	Contact CSL Behring for facility details	Rochester	Minnesota
United States	Contact CSL Behring for facility details	St. Louis	Missouri
United States	Contact CSL Behring for facility details	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sleasman JW, Duff CM, Dunaway T, Rojavin MA, Stein MR. Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).	AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.	During each infusion, and within 48 or 72 hours after the end of each infusion.	Yes
Primary	Influence of Infusion Rate on Temporally-Associated AEs	The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (= 4 mg/kg/min, = 8 mg/kg/min, and > 8 and = 12 mg/kg/min).; AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion.	Within 72 hours after each infusion	Yes
Primary	Rate of AEs by Severity and Relationship	The AE rate was the number of AEs over the number of infusions administered.; Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities.; At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.	For the duration of the study, up to approximately 29 months	Yes
Primary	Number of Subjects With Clinically Significant Changes in Vital Signs.	Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.	Before, during, and after each infusion.	Yes
Secondary	Annualized Rate of Acute Serious Bacterial Infections.	The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.; Acute serious bacterial infections included pneumonia, bacteremia / septicemia, osteomyelitis / septic arthritis, bacterial meningitis, and visceral abscess.	For the duration of the study, up to approximately 29 months	No
Secondary	Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.		For the duration of the study, up to approximately 29 months.	No
Secondary	Number of Days of Hospitalization.		For the duration of the study, up to approximately 29 months	No
Secondary	Annualized Rate of Any Infection.	The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.; Infections were classified as all AEs with the system organ class "infections and infestations" and AEs with the preferred term "conjunctivitis".	For the duration of the study, up to approximately 29 months.	Yes
Secondary	Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.	Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed.	Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.	No

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