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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01458171 |
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Date of registration:
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12/10/2011 |
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Primary sponsor: |
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Public title:
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Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
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Scientific title:
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A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01458171 |
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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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Countries of recruitment
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Japan
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Contacts
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Name:
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Shoko Hakamazuka |
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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 participated in study ZLB06_002CR and who have tolerated IgPro20
well.
- Written informed consent by the subject/parent/legally acceptable representative.
Written assent for an underage subject (=7 years at the time of obtaining informed
consent), as far as possible.
Exclusion Criteria:
- Ongoing serious bacterial infections (SBIs) (pneumonia, bacteremia/septicemia,
osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the
time of the first infusion.
- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (known total urine
protein concentration >0.2 g/L or urine protein ++ by dipstick).
- Pregnancy or nursing mother.
- Participation in a study with an investigational medicinal product (IMP) within 3
months prior to enrollment except for ZLB06_002CR.
- Subjects who are planning to donate blood during the study.
- Re-entry of subjects previously participating in the current follow-up study.
- Known or suspected antibodies to the IMP, or to excipients of the IMP.
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 Disorder
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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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Median of the individual subject's rate of adverse events per infusion
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Annualized rate of clinically documented serious bacterial infections (SBIs)
[Time Frame: 24 weeks]
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Duration of use of antibiotics for infection prophylaxis and treatment
[Time Frame: 24 weeks]
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IgG trough level
[Time Frame: 24 weeks]
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Number of days of hospitalization due to infections
[Time Frame: 24 weeks]
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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: 24 weeks]
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Number of infection episodes
[Time Frame: 24 weeks]
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Number of subjects with newly developing or worsening adverse events
[Time Frame: 24 weeks]
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Overall rate of adverse events per infusion
[Time Frame: 24 weeks]
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Percentage of infusions with subject-assessed tolerability of at least 'good'
[Time Frame: 24 to 72 hours after infusion]
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Secondary ID(s)
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ZLB07_001CR
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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