Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-01-01 @ 8:09 PM
Study NCT ID:
NCT00004695
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017074', 'term': 'Common Variable Immunodeficiency'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C067245', 'term': 'interleukin-2, polyethylene glycol-modified'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1999-05', 'completionDateStruct': {'date': '2000-03'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2000-02-24', 'studyFirstSubmitQcDate': '2000-02-24', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-02-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['common variable immunodeficiency', 'immunologic disorders and infectious disorders', 'primary immunodeficiency disease', 'rare disease'], 'conditions': ['Common Variable Immunodeficiency']}, 'descriptionModule': {'briefSummary': 'OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency.\n\nII. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.', 'detailedDescription': 'PROTOCOL OUTLINE: This is a randomized, open-label study. Patients are randomized to receive polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) or placebo.\n\nPatients receive PEG-IL-2 or placebo by subcutaneous injection weekly for 18 months. Patients maintain a daily diary for 24 months.\n\nPatients are followed every 4 months for 2 years.\n\nCompletion date provided represents the completion date of the grant per OOPD records'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'PROTOCOL ENTRY CRITERIA:\n\n--Disease Characteristics--\n\nDocumented common variable immunodeficiency defined as a reduction of serum IgG by at least 2 standard deviations\n\nIn vitro lymphocyte proliferative response to PEG-IL-2 of at least 10 times more than unstimulated cultures\n\n--Prior/Concurrent Therapy--\n\nNo biologic response modifier therapy (i.e., interferon, cyclosporin A) except prednisone (maximum 10 mg/day)\n\nConcurrent treatment with same dosage intravenous gamma-globulin for at least 6 months is required\n\n--Patient Characteristics--\n\nLife expectancy: At least 24 months\n\nOther: Not pregnant or nursing HIV negative'}, 'identificationModule': {'nctId': 'NCT00004695', 'briefTitle': 'Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency', 'organization': {'class': 'FED', 'fullName': 'FDA Office of Orphan Products Development'}, 'orgStudyIdInfo': {'id': '199/13358'}, 'secondaryIdInfos': [{'id': 'MTS-93-726-ME'}, {'id': 'MTS-FDR001162'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'PEG-interleukin-2', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Charlotte Cunningham-Rundles', 'role': 'STUDY_CHAIR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}}}}