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

• Sponsor: CSL Behring (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00168012
• Collaborator: (none)
• Enrollment: 42
• Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Agammaglobulinemia; IgG Deficiency; Common Variable Immunodeficiency	Drug: Immunoglobulins Intravenous (Human)	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)
• Study Start Date: Sep 1, 2004
• Actual Study Completion Date: Sep 1, 2005

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• CSL Behring

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00168012
• Other Study ID Numbers: ZLB04_005CR
• First Posted: Sep 14, 2005
• Last Update Posted: Feb 11, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: Immunoglobulin intravenous; Agammaglobulinemia; Hypogammaglobulinemia; Common variable immunodeficiency; Immunoglobulin G; Children
• Additional relevant MeSH terms: Agammaglobulinemia; IgG Deficiency; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies

Study Results

No Results Posted as of Feb 11, 2011