Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-26 @ 7:55 AM
Study NCT ID:
NCT01429792
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2011-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '8008218590', 'title': 'Medical Communications', 'organization': 'Hoffman-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Week 24', 'description': 'Safety population includes all enrolled participants', 'eventGroups': [{'id': 'EG000', 'title': 'Pegylated Interferon Alfa 2a (Peginterferon)', 'description': 'Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.', 'otherNumAtRisk': 1013, 'otherNumAffected': 131, 'seriousNumAtRisk': 1013, 'seriousNumAffected': 50}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 103}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 57}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 103}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemolytic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neutropenic fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Optic nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Optic Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal wall abcess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tubo-ovarian abcess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pancreatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cerebral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Scrotal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anal spincterotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Inguinal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sigmoidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Post thrombotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1013, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa 2a (Peginterferon)', 'description': 'Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '18.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with CHC Genotype 1 \\& 4 at week 12'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa 2a (Peginterferon)', 'description': 'Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000', 'lowerLimit': '46.8', 'upperLimit': '54.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with CHC Genotype 1 \\& 4 at Week 12'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa 2a (Peginterferon)', 'description': 'Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '19.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with CHC Genotype 1 \\& 4 at Week 24'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Rapid Virologic Response (RVR) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa 2a (Peginterferon)', 'description': 'Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.03', 'groupId': 'OG000', 'lowerLimit': '42.3', 'upperLimit': '53.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with CHC Genotype 2 \\& 3 at Week 4'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa 2a (Peginterferon)', 'description': 'Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.97', 'groupId': 'OG000', 'lowerLimit': '46.2', 'upperLimit': '57.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with CHC Genotype 2 \\& 3 at Week 4'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa 2a (Peginterferon)', 'description': 'Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '10.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with CHC Genotype 2 \\& 3 at Week 24'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With pEVR to Study Treatment at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa 2a (Peginterferon)', 'description': 'Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.'}], 'timeFrame': 'Week 12', 'description': 'The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.', 'reportingStatus': 'POSTED', 'populationDescription': 'As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4.'}, {'type': 'SECONDARY', 'title': 'Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa 2a (Peginterferon)', 'description': 'Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.'}], 'timeFrame': 'Week 12', 'description': 'The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa 2a (Peginterferon)', 'description': 'Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.'}], 'timeFrame': 'Week 24', 'description': 'The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pegylated Interferon Alfa 2a (Peginterferon)', 'description': 'Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1013'}]}, {'type': 'Genotype 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '687'}]}, {'type': 'Genotype 2 & 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '305'}]}, {'type': 'Genotype 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '607'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '406'}]}], 'dropWithdraws': [{'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '67'}]}, {'type': 'Unknown Disposition', 'reasons': [{'groupId': 'FG000', 'numSubjects': '94'}]}, {'type': 'Negative HCV-RNA at Week 4', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Negative HCV-RNA at Week 12', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Decrease of less than 2-log in HCV RNA', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Positive HCV-RNA at Week 24', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '88'}]}]}], 'recruitmentDetails': 'Male and female participants, 18 years of age and above with serologically proven genotype 1, 2, 3 or 4 CHC and treated with the standard combination treatment of peginterferon alfa-2a (Pegasys) and ribavirin (Copegus).', 'preAssignmentDetails': 'A total of 1013 participants were enrolled in the study and 607 of them completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1013', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pegylated Interferon Alfa 2a (Peginterferon)', 'description': 'Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'spread': '11.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '380', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '632', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who enrolled in the study'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1013}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2013-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-20', 'studyFirstSubmitDate': '2011-09-05', 'resultsFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2011-09-05', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-20', 'studyFirstPostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment', 'timeFrame': 'Week 12', 'description': 'The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.'}, {'measure': 'Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment', 'timeFrame': 'Week 12', 'description': 'The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment'}, {'measure': 'Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24', 'timeFrame': 'Week 24', 'description': 'The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment'}, {'measure': 'Percentage of Participants With Rapid Virologic Response (RVR) at Week 4', 'timeFrame': 'Week 4', 'description': 'The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.'}, {'measure': 'Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment', 'timeFrame': 'Week 4', 'description': 'The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.'}, {'measure': 'Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24', 'timeFrame': 'Week 24', 'description': 'The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With pEVR to Study Treatment at Week 12', 'timeFrame': 'Week 12', 'description': 'The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.'}, {'measure': 'Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment', 'timeFrame': 'Week 12', 'description': 'The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment.'}, {'measure': 'Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24', 'timeFrame': 'Week 24', 'description': 'The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment.'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \\& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 \\& 3) or 48 weeks (genotype 1 \\& 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test\n* Documented pre-treatment HCV RNA quantitative result\n* Compensated liver disease (Child-Pugh Grade A)\n* Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)\n\nExclusion Criteria:\n\n* Decompensated liver disease (Child-Pugh Class B or C cirrhosis)\n* Co-infection with active hepatitis A and/or hepatitis B\n* History or evidence of a medical condition associated with liver disease other than HCV\n* Signs and symptoms of hepatocellular carcinoma\n* History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease\n* Therapy with antineoplastic treatment \\</= 6 months prior to study day\n* Diabetes mellitus in subjects receiving an insulin therapy\n* Evidence of severe retinopathy\n* Pregnant or breast-feeding women, and male partners of women who are pregnant'}, 'identificationModule': {'nctId': 'NCT01429792', 'briefTitle': 'A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multi-Center Study Evaluating the Rate of Genotype 1, 2, 3 & 4 Chronic Hepatitis C Patients With Slow Response / Non-rapid Viral Response to Anti-Viral Treatment of Pegasys (Peginterferon Alfa 2a) in Combination With Copegus (Ribavirin)', 'orgStudyIdInfo': {'id': 'ML21779'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'interventionNames': ['Drug: peginterferon alfa-2a [Pegasys]', 'Drug: ribavirin [Copegus]']}], 'interventions': [{'name': 'peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': 'standard treatment, subcutaneously weekly', 'armGroupLabels': ['Single Arm']}, {'name': 'ribavirin [Copegus]', 'type': 'DRUG', 'description': 'standard treatment, orally daily', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'facility': 'Haemek Hospital; Gastroenterology', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'zip': '77444', 'city': 'Ashdod', 'country': 'Israel', 'facility': 'Clalit City Ashdod MC; Liver Clinic', 'geoPoint': {'lat': 31.79213, 'lon': 34.64966}}, {'zip': '78278', 'city': 'Ashkelon', 'country': 'Israel', 'facility': 'Barzilai MC; Gastroenterology', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'city': 'Bat Yam', 'country': 'Israel', 'facility': 'Batyamon; Liver Unit', 'geoPoint': {'lat': 32.02379, 'lon': 34.75185}}, {'zip': '8410101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center; Liver Unit', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '84105', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center; Gastroenterology', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center; Gastroenterology - Liver Unit', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '33394', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Bnei-Zion Medical Center; Gastroenterology', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '34362', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Carmel Hospital; Liver Unit', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '58100', 'city': 'Holon', 'country': 'Israel', 'facility': 'Wolfson Hospital; Gastroenterology Unit', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Hospital; Liver Unit', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '95146', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Clalit Strauss MC', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center; Gastroenterology', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '22100', 'city': 'Nahariya', 'country': 'Israel', 'facility': 'Naharyia / Western Galilee MC; Gastro Unit', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}, {'city': 'Nazareth', 'country': 'Israel', 'facility': 'Holy Family Medical Center; Gastroenterology', 'geoPoint': {'lat': 32.70087, 'lon': 35.29719}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center; Gastroenterology - Liver Unit', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Hasharon Mc; Gastroenterology', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Chaim Sheba Medical Center; Gastroenterology', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '76100', 'city': 'Rehovot', 'country': 'Israel', 'facility': 'Kaplan Medical Center; Gastroenterology Unit', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '75299', 'city': 'Rishon LeZiyyon', 'country': 'Israel', 'facility': 'Clalit Pinsker Rishon; Liver Clinic', 'geoPoint': {'lat': 31.97102, 'lon': 34.78939}}, {'zip': '13110', 'city': 'Safed', 'country': 'Israel', 'facility': 'Rebecca Sieff; Gastroenterology', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky / Ichilov Hospital; Gastroenterology - Liver Unit', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '64353', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Clalit Zamenhoff', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '67891', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Maccabi Health Services MC', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tiberias', 'country': 'Israel', 'facility': 'Poria Hospital; Gastroenterology', 'geoPoint': {'lat': 32.79221, 'lon': 35.53124}}, {'zip': '6093000', 'city': 'Ẕerifin', 'country': 'Israel', 'facility': 'Assaf Harofeh; Gastroenterology', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}