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

Phase 3

Completed

• Conditions: Agammaglobulinemia; Common Variable Immunodeficiency; IgG Deficiency
• Interventions: Drug: Immunoglobulins Intravenous (Human)

• Registration Number: NCT00322556
• Lead Sponsor: CSL Behring

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-05-05
• Study First Submitted QC: 2006-05-05
• Study First Posted: 2006-05-08
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2012-09
• Results First Submitted: 2012-09-27
• Results First Submitted QC: 2012-09-27
• Last Update Submitted: 2012-09-27
• Results First Posted: 2012-10-26
• Last Update Posted: 2012-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IgPro10	Immunoglobulins Intravenous (Human)	See Intervention Description

Primary Outcome Measures

Name	Time	Method
The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).	During each infusion, and within 48 or 72 hours after the end of each infusion.	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.
Influence of Infusion Rate on Temporally-Associated AEs	Within 72 hours after each infusion	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.
Rate of AEs by Severity and Relationship	For the duration of the study, up to approximately 29 months	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.
Number of Subjects With Clinically Significant Changes in Vital Signs.	Before, during, and after each infusion.	Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.

Secondary Outcome Measures

Name	Time	Method
Annualized Rate of Acute Serious Bacterial Infections.	For the duration of the study, up to approximately 29 months	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.
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.
Number of Days of Hospitalization.	For the duration of the study, up to approximately 29 months
Annualized Rate of Any Infection.	For the duration of the study, up to approximately 29 months.	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".
Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.	Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.	Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed.

Trial Locations

Locations (1)

Contact CSL Behring for facility details; 🇺🇸 Dallas, Texas, United States