Viewing Study NCT00919633

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Ignite Creation Date: 2025-12-25 @ 2:49 AM
Ignite Modification Date: 2025-12-30 @ 4:12 PM
Study NCT ID: NCT00919633
Status: COMPLETED
Last Update Posted: 2019-10-09
First Post: 2009-06-10
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077190', 'term': 'Interferon alpha-2'}, {'id': 'C417083', 'term': 'peginterferon alfa-2b'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarah.mische@medtronic.com', 'phone': '763-505-4594', 'title': 'Study Trial Manager', 'organization': 'Medtronic, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected the duration of the study from activation to closure.', 'eventGroups': [{'id': 'EG000', 'title': 'PEGINTRON 1.5', 'description': 'subcutaneous weekly for 48 weeks\n\npeginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks\n\nribavirin, USP : All patients will receive oral ribavirin', 'otherNumAtRisk': 28, 'otherNumAffected': 28, 'seriousNumAtRisk': 28, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'INTRON A 80,000', 'description': 'continuous subcutaneous infusion for 48 weeks\n\nexternal drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b\n\ninterferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks\n\nribavirin, USP : All patients will receive oral ribavirin', 'otherNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'INTRON A 120,000', 'description': 'continuous subcutaneous infusion for 48 weeks\n\nexternal drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b\n\ninterferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks\n\nribavirin, USP : All patients will receive oral ribavirin', 'otherNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'INTRON A 160,000', 'description': 'continuous subcutaneous infusion for 48 weeks\n\nexternal drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b\n\ninterferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks\n\nribavirin, USP : All patients will receive oral ribavirin', 'otherNumAtRisk': 26, 'otherNumAffected': 26, 'seriousNumAtRisk': 26, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gingival Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Disturbance in Attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Memory Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypogeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, 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'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory Tract Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 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{'primaryOutcomes': [{'measure': 'Viral Load: Incidence of Sustained Virologic Response (SVR)', 'timeFrame': '24 weeks after treatment is complete'}], 'secondaryOutcomes': [{'measure': 'Rapid Virologic Response (RVR)', 'timeFrame': 'Study Week 4'}, {'measure': 'Early Virologic Response (EVR)', 'timeFrame': 'Study week 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hepatitis C', 'HCV', 'genotype', 'sustained virological response', 'rapid virological response', 'interferon'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://ctep.cancer.gov', 'label': 'Common terminology criteria for adverse events, version 3.0'}, {'url': 'http://www.ICMJE.org', 'label': 'International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Publication ethics: sponsorship, authorship and accountability.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis C infection as compared to patients who receive standard treatment.', 'detailedDescription': 'The study will include patients who are diagnosed with chronic hepatitis C genotype 1 infection and who have received no previous interferon or other anti-HCV treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed patient consent form\n* Genotype 1 chronic HCV with detectable HCV RNA\n* No previous treatment for HCV infection\n* Hepatitis B and human immunodeficiency virus negative at screening visit\n* Able and willing to follow contraception requirements\n* Screening laboratory values, test, and physical exam within acceptable ranges\n* Weight between 40 kg and 125 kg\n* Proficiency in the use of the external pump infusion system\n\nExclusion Criteria:\n\n* Current or planned enrollment in another investigational device or drug study\n* Anticipated inability to complete all clinic visits and comply with study procedures\n* History of, or any current medical condition, which could impact the safety of the subject during the study\n* Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV\n* Alcoholism or substance abuse with \\<6 documented months of sobriety\n* Known allergy or sensitivity to interferons or ribavirin\n* Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study'}, 'identificationModule': {'nctId': 'NCT00919633', 'acronym': 'COPE-HCV', 'briefTitle': 'Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Corporate Technologies and New Ventures'}, 'officialTitle': 'COPE-HCV: Continuous Interferon Delivery Via the Medtronic Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV', 'orgStudyIdInfo': {'id': '4316001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: interferon alfa-2b (dose 1)', 'description': 'continuous subcutaneous infusion for 48 weeks', 'interventionNames': ['Drug: interferon alfa-2b', 'Drug: ribavirin, USP', 'Device: external drug infusion pump']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: interferon alfa-2b (dose 2)', 'description': 'continuous subcutaneous infusion for 48 weeks', 'interventionNames': ['Drug: interferon alfa-2b', 'Drug: ribavirin, USP', 'Device: external drug infusion pump']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: interferon alfa-2b (dose 3)', 'description': 'continuous subcutaneous infusion for 48 weeks', 'interventionNames': ['Drug: interferon alfa-2b', 'Drug: ribavirin, USP', 'Device: external drug infusion pump']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4: peginterferon alfa-2b (1.5 μg/kg)', 'description': 'subcutaneous weekly for 48 weeks', 'interventionNames': ['Drug: peginterferon alfa-2b', 'Drug: ribavirin, USP']}], 'interventions': [{'name': 'interferon alfa-2b', 'type': 'DRUG', 'otherNames': ['INTRON® A'], 'description': 'subcutaneous continuous infusion at one of three doses for 48 weeks', 'armGroupLabels': ['Group 1: interferon alfa-2b (dose 1)', 'Group 2: interferon alfa-2b (dose 2)', 'Group 3: interferon alfa-2b (dose 3)']}, {'name': 'peginterferon alfa-2b', 'type': 'DRUG', 'otherNames': ['PEGINTRON™'], 'description': '1.5 μg/kg subcutaneous weekly for 48 weeks', 'armGroupLabels': ['Group 4: peginterferon alfa-2b (1.5 μg/kg)']}, {'name': 'ribavirin, USP', 'type': 'DRUG', 'otherNames': ['Rebetol®'], 'description': 'All patients will receive oral ribavirin', 'armGroupLabels': ['Group 1: interferon alfa-2b (dose 1)', 'Group 2: interferon alfa-2b (dose 2)', 'Group 3: interferon alfa-2b (dose 3)', 'Group 4: peginterferon alfa-2b (1.5 μg/kg)']}, {'name': 'external drug infusion pump', 'type': 'DEVICE', 'otherNames': ['Medtronic MiniMed™ Paradigm® Insulin Pump Infusion System'], 'description': 'pump delivery system for continuous subcutaneous infusion of interferon alfa-2b', 'armGroupLabels': ['Group 1: interferon alfa-2b (dose 1)', 'Group 2: interferon alfa-2b (dose 2)', 'Group 3: interferon alfa-2b (dose 3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Clinical Research Institute', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Andrew Muir, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Clinical Research Institute'}, {'name': 'Sarah Mische, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medtronic Ventures and New Therapies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Corporate Technologies and New Ventures', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}