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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00322556
Other study ID # ZLB05_006CR
Secondary ID
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


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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