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

September 27, 2012 updated by: CSL Behring

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Contact CSL Behring for facility details
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Contact CSL Behring for facility details
    • Florida
      • North Palm Beach, Florida, United States, 33408
        • Contact CSL Behring for facility details
      • St. Petersburg, Florida, United States, 33701
        • Contact CSL Behring for facility details
    • Indiana
      • Fort Wayne, Indiana, United States, 46815
        • Contact CSL Behring for facility details
      • Indianapolis, Indiana, United States, 46202
        • Contact CSL Behring for facility details
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Contact CSL Behring for facility details
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Contact CSL Behring for facility details
    • Missouri
      • St. Louis, Missouri, United States, 63104-1095
        • Contact CSL Behring for facility details
    • Texas
      • Dallas, Texas, United States, 75230
        • Contact CSL Behring for facility details

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 71 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IgPro10
See Intervention Description
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Rate of Acute Serious Bacterial Infections.
Time Frame: 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.
For the duration of the study, up to approximately 29 months
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.
For the duration of the study, up to approximately 29 months.
Number of Days of Hospitalization.
Time Frame: For the duration of the study, up to approximately 29 months
For the duration of the study, up to approximately 29 months
Annualized Rate of Any Infection.
Time Frame: 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".
For the duration of the study, up to approximately 29 months.
Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.
Time Frame: 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.
Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Behring

Investigators

  • Study Director: Program Coordinator, CSL Behring

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 5, 2006

First Submitted That Met QC Criteria

May 5, 2006

First Posted (Estimate)

May 8, 2006

Study Record Updates

Last Update Posted (Estimate)

October 26, 2012

Last Update Submitted That Met QC Criteria

September 27, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZLB05_006CR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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