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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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7 April 2015 |
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Main ID: |
NCT00004695 |
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Date of registration:
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24/02/2000 |
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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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Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency
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Scientific title:
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Date of first enrolment:
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September 1997 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00004695 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Contacts
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Name:
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Charlotte Cunningham-Rundles |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mount Sinai School of Medicine |
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Key inclusion & exclusion criteria
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PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Documented common variable immunodeficiency defined as a reduction of serum IgG by at
least 2 standard deviations
In vitro lymphocyte proliferative response to PEG-IL-2 of at least 10 times more than
unstimulated cultures
--Prior/Concurrent Therapy--
No biologic response modifier therapy (i.e., interferon, cyclosporin A) except prednisone
(maximum 10 mg/day)
Concurrent treatment with same dosage intravenous gamma-globulin for at least 6 months is
required
--Patient Characteristics--
Life expectancy: At least 24 months
Other: Not pregnant or nursing HIV negative
Age minimum:
2 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Common Variable Immunodeficiency
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Intervention(s)
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Drug: PEG-interleukin-2
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Secondary ID(s)
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MTS-FDR001162
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199/13358
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MTS-93-726-ME
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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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