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

Tracking Information
First Received Date ^ICMJE	September 12, 2005
Last Updated Date	October 22, 2008
Start Date ^ICMJE	September 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: September 12, 2005)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00168012 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 12, 2005)	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
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
Official Title ^ICMJE	An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)
Brief 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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency
Intervention ^ICMJE	Drug: Immunoglobulins Intravenous (Human)
Study Arms / Comparison Groups
Publications *	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. Epub 2007 May 4.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	42
Completion Date	September 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	3 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00168012
Responsible Party
Study ID Numbers ^ICMJE	ZLB04_005CR
Study Sponsor ^ICMJE	CSL Behring
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	CSL Behring
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP