Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary Immunodeficiency
Tracking Information | |||||
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First Received Date ICMJE | July 26, 2011 | ||||
Last Updated Date | May 16, 2012 | ||||
Start Date ICMJE | September 2011 | ||||
Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01406470 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary Immunodeficiency | ||||
Official Title ICMJE | An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in Subjects With Primary Immunodeficiency | ||||
Brief Summary | The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases. |
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Detailed Description | This is an open-label, single-arm, historically controlled, prospective, multicenter phase III study to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases. Subject will be infused every 21 to 28 days according to their previous IVIG treatment schedule. Subjects treated every 28 days will receive 13 study IVIG infusions. Subject treated every 21 days will receive 17 study IVIG infusions. Duration of treatment:The total duration of treatment is 12 months. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Immunologic Deficiency Syndrome | ||||
Intervention ICMJE | Drug: Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™
IVIG-SN™ 10g/200mL, dose is 300-900 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with IVIG-SN™ will be 12 months with a 3 month follow-up.
Other Names:
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Study Arm (s) | Experimental: IVIG-SN™
Immune Globulin Intravenous (Human) 5% Liquid
Intervention: Drug: Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™ |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Enrollment ICMJE | 45 | ||||
Estimated Completion Date | August 2013 | ||||
Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 2 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States, Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01406470 | ||||
Other Study ID Numbers ICMJE | IVIG_SN_P3, IVIG_SN_P3 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Green Cross Corporation | ||||
Study Sponsor ICMJE | Green Cross Corporation | ||||
Collaborators ICMJE | Atlantic Research Group | ||||
Investigators ICMJE |
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Information Provided By | Green Cross Corporation | ||||
Verification Date | May 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |