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

NCT00168025 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2012-06-06

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the effect of IgPro10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.

As secondary endpoints the rate of overall infections, the tolerability and safety of IgPro10 are studied.

A part of the patients are participating in a pharmacokinetic substudy.

Conditions

  • Agammaglobulinemia
  • IgG Deficiency
  • Common Variable Immunodeficiency

Interventions

DRUG

Immunoglobulins Intravenous (Human)

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Program Director · CSL Behring

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Completion
2006-03-31

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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 NCT00168025 on ClinicalTrials.gov