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OpenTrials
Completed

NCT Number: NCT00168012

Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)

The purpose of this study is to demonstrate the effect of IVIG-F10 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 IVIG-F10 are studied.

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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
  • Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10

Key Exclusion Criteria:

  • Allergic reactions to immunoglobulins or other blood products
  • Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day
  • History of cardiac insufficiency
  • Epilepsia

Treatment and study plan

Immunoglobulins Intravenous (Human)

Drug

Primary outcomes

  1. Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.

Secondary outcomes

  1. Rate of acute serious bacterial infections

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

  3. Number of infections

  4. Rate, severity and relationship of all adverse events

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)

Important dates

Study start
2004
Study completion
2005
First posted
Sep 14, 2005
Registry last updated
Feb 11, 2011

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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