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OpenTrials
Completed

NCT Number: NCT00168025

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

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.

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Key information

Conditions

Agammaglobulinemia Blood Protein Disorders Common Variable Immunodeficiency Dysgammaglobulinemia Hematologic Diseases Hemic and Lymphatic Diseases IgG Deficiency Immune System Diseases Immunologic Deficiency Syndromes Lymphatic Diseases Lymphoproliferative Disorders

Age range

3 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Patients with primary immunodeficiency
  • Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at least 6 months

Key Exclusion Criteria:

  • Newly diagnosed PID
  • Allergic reactions to immunoglobulins or other blood products
  • Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
  • Concomitant diseases such as hypoalbuminemia, protein-losing enteropathies, kidney diseases with proteinuria, malignancies of lymphoid cells (e.g. lymphocytic leukemia), and recent history of migraine
  • History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension

Treatment and study plan

Immunoglobulins Intravenous (Human)

Drug

Primary outcomes

  1. Annualized rate of acute serious bacterial infections

Secondary outcomes

  1. Number of infections

  2. Number of days out of work / school due to underlying PID

  3. Adverse events temporally associated with study drug infusion

  4. Trough levels of total IgG serum concentrations

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)

Important dates

Study start
2004
Study completion
2006
First posted
Sep 14, 2005
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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