Phase 3 N=55 Treatment

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

Agammaglobulinemia · IgG Deficiency · Common Variable Immunodeficiency

Bottom Line

View on ClinicalTrials.gov: NCT00322556 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Oct 2012

Primary outcome: Primary: The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). — 0.073; 0.141; 0.150 Proportion of infusions

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Immunoglobulins Intravenous (Human) (Drug)
Age: Pediatric, Adult, Older Adult · 4+ yrs
Sex: All
Sponsor: CSL Behring
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).	0.073; 0.141; 0.150	—
PRIMARY Influence of Infusion Rate on Temporally-Associated AEs	23; 153; 30; 10; 54; 2	—
PRIMARY Rate of AEs by Severity and Relationship	0.467; 0.280; 0.058; 0.610; 0.088; 0.048	—
PRIMARY Number of Subjects With Clinically Significant Changes in Vital Signs.	—	—
SECONDARY Annualized Rate of Acute Serious Bacterial Infections.	0.018	—
SECONDARY Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.	8.5	—
SECONDARY Number of Days of Hospitalization.	0.0	—
SECONDARY Annualized Rate of Any Infection.	1.600	—
SECONDARY Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.	9.72	—

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)

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00322556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.