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NCT00168012 Clinical Trial

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

Common Variable Immunodeficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00168012
Other study ID # ZLB04_005CR
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated February 10, 2011
Start date September 2004
Est. completion date September 2005

Study information
Verified date February 2011
Source CSL Behring
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 70 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Immunoglobulins Intravenous (Human)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
CSL Behring

References & Publications (1)

Berger M, Cunningham-Rundles C, Bonilla FA, Melamed I, Bichler J, Zenker O, Ballow M. Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseases. J Clin Immunol. 2007 Sep;27(5):503-9. E — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Rate of acute serious bacterial infections
Secondary Number of days out of work/school due to underlying PID
Secondary Number of infections
Secondary Rate, severity and relationship of all adverse events
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