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

NCT00322556 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2012-10-26

Study results available
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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.

Conditions

  • Agammaglobulinemia
  • IgG Deficiency
  • Common Variable Immunodeficiency

Interventions

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

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Program Coordinator · CSL Behring

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
71 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00322556 on ClinicalTrials.gov