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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 October 2017 |
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Main ID: |
NCT00542997 |
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Date of registration:
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11/10/2007 |
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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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Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
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Scientific title:
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A Multicentre Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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51 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00542997 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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France
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Germany
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Italy
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Poland
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Romania
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Spain
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Sweden
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Switzerland
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United Kingdom
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Contacts
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Name:
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Stephen Jolles, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of Wales, Cardiff, UK |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects with primary humoral immunodeficiency, namely with a diagnosis of Common
Variable Immunodeficiency (CVID) as defined by the Pan-American Group for
Immunodeficiency (PAGID) and European Society for Immunodeficiencies (ESID), X-linked
agammaglobulinemia (XLA) as defined by PAGID and ESID, or Autosomal Recessive
Agammaglobulinemia
- Chest X-ray or CT scan obtained within 1 year prior to enrolment
Exclusion Criteria:
- Newly diagnosed PID, i.e. subjects who have not previously received immunoglobulin
replacement therapy
- Ongoing serious bacterial infection at the time of screening
- Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma
and immunodeficiency with thymoma
- Allergic or other severe reactions to immunoglobulins or other blood products
associated with high anti-IgA
Additional criteria may apply and examination by an investigator is required to determine
eligibility.
Age minimum:
2 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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X-linked Agammaglobulinemia
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Autosomal Recessive Agammaglobulinemia
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Common Variable Immunodeficiency
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Intervention(s)
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Biological: Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)
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Primary Outcome(s)
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Total Serum IgG Trough Levels
[Time Frame: Up to 6 months prior to first IgPro20 treatment (Pre-study treatment) and Week 12 to 17 (IgPro20 treatment)]
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Secondary Outcome(s)
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Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population)
[Time Frame: Efficacy period: week 12 to week 40 after study start or to the completion visit]
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Annual Rate of the Number of Days of Hospitalization Due to Infections
[Time Frame: Efficacy period: week 12 to week 40 after study start or to the completion visit]
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Annual Rate of Antibiotic Use for Infection Prophylaxis and Treatment
[Time Frame: Efficacy period: week 12 to week 40 after study start or to the completion visit]
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Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population)
[Time Frame: Efficacy period: week 12 to week 40 after study start or to the completion visit]
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Annual Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections
[Time Frame: Efficacy period: week 12 to week 40 after study start or to the completion visit]
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Annual Rate of Infection Episodes
[Time Frame: Efficacy period: week 12 to week 40 after study start or to the completion visit]
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Secondary ID(s)
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1460
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ZLB06_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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