Phase 3 N=49 Treatment

Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy

Primary Immune Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT00419341 ↗

Enrolled (actual)

Serious AEs

14.3%

Results posted

Jan 2013

Primary outcome: Primary: Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population) — 0.00 SBIs per subject year

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Human Normal Immunoglobulin for Subcutaneous Administration (Biological)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: CSL Behring
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population)	0.00	—
PRIMARY Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG)	105.6; 103.2	—
SECONDARY Annualized Rate of Clinically Documented SBIs (ITT Population)	0.00	—
SECONDARY Annualized Rate of Clinically Documented SBIs (PPE Population)	0.00	—
SECONDARY Annualized Rate of Infection Episodes	2.76	—
SECONDARY Number of Infection Episodes (Serious and Non-serious)	96	—
SECONDARY Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections	2.06	—
SECONDARY Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections	71	—
SECONDARY Annualized Rate of Hospitalization Due to Infection	0.20	—
SECONDARY Number of Days of Hospitalization Due to Infections	7	—
SECONDARY Use of Antibiotics for Infection Prophylaxis and Treatment	48.52	—
SECONDARY Total Serum IgG Trough Levels	12.53	—
SECONDARY Maximum Concentration (Cmax) of Total Serum IgG at Steady State	16.16	—
SECONDARY Tmax at Steady State	3.118	—

Summary

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).

Eligibility Criteria

Inclusion Criteria

Male or female aged 2 to 75 years
Subjects with primary humoral immunodeficiency, namely with a diagnosis of: CVID (Common Variable Immunodeficiency) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or XLA (X-linked Agammaglobulinemia)
Written informed consent

Exclusion Criteria

Newly diagnosed PID
Evidence of an active serious infection at the time of screening (i.e., but not limited to: bacteremia/septicemia, pneumonia, fungal osteomyelitis)
Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma
Known hyperprolinemia
Hypoalbuminemia, protein-losing enteropathies, and any proteinuria
Allergic reactions to immunoglobulins or other blood products
Known antibodies to Immunoglobulin A (IgA)
The subject is receiving steroids (oral and parenteral, daily ≥ 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants
Female who is pregnant, breast feeding or planning a pregnancy during the course of the study
Participation in a study with an investigational product other than (IVIG) within 1 month prior to enrollment
A positive result at screening on any of the following viral markers: Human Immunodeficiency Virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV)
Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration > 2.5 times the upper normal limit (UNL)
Creatinine concentration > 1.5 times the UNL
Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00419341). 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.