Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency |
Drug: Immunoglobulins Intravenous (Human) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID) |
- 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. ] [ Designated as safety issue: Yes ]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 [ Time Frame: Within 72 hours after each infusion ] [ Designated as safety issue: Yes ]
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 [ Time Frame: For the duration of the study, up to approximately 29 months ] [ Designated as safety issue: Yes ]
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. [ Time Frame: Before, during, and after each infusion. ] [ Designated as safety issue: Yes ]Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
- Annualized Rate of Acute Serious Bacterial Infections. [ Time Frame: For the duration of the study, up to approximately 29 months ] [ Designated as safety issue: No ]
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. [ Time Frame: For the duration of the study, up to approximately 29 months. ] [ Designated as safety issue: No ]
- Number of Days of Hospitalization. [ Time Frame: For the duration of the study, up to approximately 29 months ] [ Designated as safety issue: No ]
- Annualized Rate of Any Infection. [ Time Frame: For the duration of the study, up to approximately 29 months. ] [ Designated as safety issue: Yes ]
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. [ Time Frame: Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule. ] [ Designated as safety issue: No ]Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed.
| Enrollment: | 55 |
| Study Start Date: | November 2005 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 4 Years to 71 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Contact CSL Behring for facility details | |
| Los Angeles, California, United States, 90027 | |
| United States, Colorado | |
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| Centennial, Colorado, United States, 80112 | |
| United States, Florida | |
| Contact CSL Behring for facility details | |
| North Palm Beach, Florida, United States, 33408 | |
| Contact CSL Behring for facility details | |
| St. Petersburg, Florida, United States, 33701 | |
| United States, Indiana | |
| Contact CSL Behring for facility details | |
| Fort Wayne, Indiana, United States, 46815 | |
| Contact CSL Behring for facility details | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Contact CSL Behring for facility details | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Minnesota | |
| Contact CSL Behring for facility details | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Contact CSL Behring for facility details | |
| St. Louis, Missouri, United States, 63104-1095 | |
| United States, Texas | |
| Contact CSL Behring for facility details | |
| Dallas, Texas, United States, 75230 | |
| Study Director: | Program Coordinator | CSL Behring |
More Information
Additional Information:
Publications:
| Responsible Party: | CSL Behring |
| ClinicalTrials.gov Identifier: | NCT00322556 History of Changes |
| Other Study ID Numbers: | ZLB05_006CR |
| Study First Received: | May 5, 2006 |
| Results First Received: | September 27, 2012 |
| Last Updated: | September 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by CSL Behring:
|
Immunoglobulin Intravenous Agammaglobulinemia Hypogammaglobulinemia |
Common variable immunodeficiency Immunoglobulin G Children |
Additional relevant MeSH terms:
|
Agammaglobulinemia Common Variable Immunodeficiency Immunologic Deficiency Syndromes IgG Deficiency Blood Protein Disorders Hematologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immune System Diseases |
Dysgammaglobulinemia Immunoglobulins Antibodies Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013