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

Information source: CSL Behring
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Agammaglobulinemia; IgG Deficiency; Common Variable Immunodeficiency

Intervention: Immunoglobulins Intravenous (Human) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: CSL Behring

Summary

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.

Clinical Details

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 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 outcome:

Rate of acute serious bacterial infections

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

Number of infections

Rate, severity and relationship of all adverse events

Eligibility

Minimum age: 3 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: September 2004
Ending date: January 2006
Last updated: March 7, 2006

Page last updated: March 21, 2008

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