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

Primary Purpose

Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Immunoglobulins Intravenous (Human)
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agammaglobulinemia focused on measuring Immunoglobulin Intravenous, Agammaglobulinemia, Hypogammaglobulinemia, Common variable immunodeficiency, Immunoglobulin G, Children

Eligibility Criteria

4 Years - 71 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IgPro10

Arm Description

See Intervention Description

Outcomes

Primary Outcome Measures

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.
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.
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.
Number of Subjects With Clinically Significant Changes in Vital Signs.
Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.

Secondary Outcome Measures

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.
Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.
Number of Days of Hospitalization.
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".
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.

Full Information

First Posted
May 5, 2006
Last Updated
September 27, 2012
Sponsor
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT00322556
Brief Title
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
Official Title
A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
Keywords
Immunoglobulin Intravenous, Agammaglobulinemia, Hypogammaglobulinemia, Common variable immunodeficiency, Immunoglobulin G, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IgPro10
Arm Type
Experimental
Arm Description
See Intervention Description
Intervention Type
Drug
Intervention Name(s)
Immunoglobulins Intravenous (Human)
Intervention Description
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
Primary Outcome Measure Information:
Title
The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).
Description
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.
Time Frame
During each infusion, and within 48 or 72 hours after the end of each infusion.
Title
Influence of Infusion Rate on Temporally-Associated AEs
Description
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.
Time Frame
Within 72 hours after each infusion
Title
Rate of AEs by Severity and Relationship
Description
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.
Time Frame
For the duration of the study, up to approximately 29 months
Title
Number of Subjects With Clinically Significant Changes in Vital Signs.
Description
Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
Time Frame
Before, during, and after each infusion.
Secondary Outcome Measure Information:
Title
Annualized Rate of Acute Serious Bacterial Infections.
Description
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.
Time Frame
For the duration of the study, up to approximately 29 months
Title
Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.
Time Frame
For the duration of the study, up to approximately 29 months.
Title
Number of Days of Hospitalization.
Time Frame
For the duration of the study, up to approximately 29 months
Title
Annualized Rate of Any Infection.
Description
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".
Time Frame
For the duration of the study, up to approximately 29 months.
Title
Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.
Description
Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed.
Time Frame
Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Program Coordinator
Organizational Affiliation
CSL Behring
Official's Role
Study Director
Facility Information:
Facility Name
Contact CSL Behring for facility details
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Contact CSL Behring for facility details
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
Contact CSL Behring for facility details
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46815
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
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City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
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City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Contact CSL Behring for facility details
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104-1095
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20217199
Citation
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.
Results Reference
result
Links:
URL
http://www.cslbehring.com/clinical-trials/contact-us.htm?registryRefNum=NCT00322556&registryName=ctgov
Description
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Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

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