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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01461018 |
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Date of registration:
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24/10/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)
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Scientific title:
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A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01461018 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yusuke Watanabe |
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Address:
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Telephone:
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Email:
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Affiliation:
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CSL Behring K.K. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects who have completed the preceding follow-up study ZLB07_001CR.
- Written informed consent by the subject/parent/legally acceptable representative.
Written assent for an underage subject (=7 years and <20 years of age at the time of
obtaining informed consent), according to the competencies of the subject.
Exclusion Criteria:
- Pregnancy or nursing mother.
- Participation in a study with an investigational medicinal product (IMP) within 3
months prior to enrollment except for study ZLB07_001CR.
- Subjects who are planning to donate blood during the study.
- Known or suspected antibodies to the IMP, or to excipients of the IMP.
- Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.
Age minimum:
N/A
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Immune Deficiency
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Intervention(s)
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Biological: Immune globulin subcutaneous (Human)
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Primary Outcome(s)
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Annualized rate of infection episodes
[Time Frame: Up to 36 months]
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Secondary Outcome(s)
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Number of subjects with adverse events (AEs)
[Time Frame: Up to 36 months]
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Percentage of subjects with adverse events (AEs)
[Time Frame: Up to 36 months]
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Annualized rate of clinically documented serious bacterial infections (SBIs)
[Time Frame: Up to 36 months]
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Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections
[Time Frame: Up to 36 months]
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Rate of AEs per infusion
[Time Frame: Up to 36 months]
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Median serum IgG concentration
[Time Frame: Up to 36 months]
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Duration of use of antibiotics for infection prophylaxis and treatment
[Time Frame: Up to 36 months]
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Number of days of hospitalization due to infections
[Time Frame: Up to 36 months]
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Secondary ID(s)
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IgPro20_3006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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