Clinical trial NCT00322556: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Agammaglobulinemia
IgG Deficiency
Common Variable Immunodeficiency
Keywords: Immunoglobulin Intravenous
Agammaglobulinemia
Hypogammaglobulinemia
Common variable immunodeficiency
Immunoglobulin G
Children
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2006-05-08
Enrollment: 55
Sex: ALL
Minimum age (years): 4
Maximum age (years): 71
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).
timeFrame: During each infusion, and within 48 or 72 hours after the end of each infusion.
measure: Influence of Infusion Rate on Temporally-Associated AEs
timeFrame: Within 72 hours after each infusion
measure: Rate of AEs by Severity and Relationship
timeFrame: For the duration of the study, up to approximately 29 months
measure: Number of Subjects With Clinically Significant Changes in Vital Signs.
timeFrame: Before, during, and after each infusion.
Secondary outcomes:
measure: Annualized Rate of Acute Serious Bacterial Infections.
timeFrame: For the duration of the study, up to approximately 29 months
measure: Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.
timeFrame: For the duration of the study, up to approximately 29 months.
measure: Number of Days of Hospitalization.
timeFrame: For the duration of the study, up to approximately 29 months
measure: Annualized Rate of Any Infection.
timeFrame: For the duration of the study, up to approximately 29 months.
measure: Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.
timeFrame: Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Contact CSL Behring for facility details
state: California
city: Centennial
country: United States
facility: Contact CSL Behring for facility details
state: Colorado
city: North Palm Beach
country: United States
facility: Contact CSL Behring for facility details
state: Florida
city: St. Petersburg
country: United States
facility: Contact CSL Behring for facility details
state: Florida
city: Fort Wayne
country: United States
facility: Contact CSL Behring for facility details
state: Indiana
city: Indianapolis
country: United States
facility: Contact CSL Behring for facility details
state: Indiana
city: Iowa City
country: United States
facility: Contact CSL Behring for facility details
state: Iowa
city: Rochester
country: United States
facility: Contact CSL Behring for facility details
state: Minnesota
city: St. Louis
country: United States
facility: Contact CSL Behring for facility details
state: Missouri
city: Dallas
country: United States
facility: Contact CSL Behring for facility details
state: Texas
Study officials:
affiliation: CSL Behring
name: Program Coordinator
role: STUDY_DIRECTOR
References:
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.