Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT01447420
Status:
COMPLETED
Last Update Posted:
2016-07-25
First Post:
2011-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment 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': 'global.trial_information@roche.com', 'phone': '+41 616878333', 'title': 'Roche Trial Information Hotline', 'organization': 'F. Hoffmann-La Roche AG'}, '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': 'Up to Week 72', 'description': 'Adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant that administers a pharmaceutical product, which does not necessarily have a causal relationship with treatment. Safety population was used which included all enrolled participants who received at least one dose of any study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants were administered peginterferon alfa-2a, 180 mcg SC weekly, 48 weeks and Ribavirin 1000 mg per day for \\< 75 kg and 1200 mg per day for \\>= 75 kg, orally daily, 48 weeks.', 'otherNumAtRisk': 129, 'otherNumAffected': 125, 'seriousNumAtRisk': 129, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 41}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'notes': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthenia', 'notes': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'notes': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Discomfort', 'notes': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain', 'notes': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 54}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 42}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 55}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 25}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 25}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Optic ischaemic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Retinal vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Perianal erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\\<) 75 kg and 1,200 mg per day for greater than or equal to \\[\\>=\\] 75 kg).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \\< 75 kg and 1,200 mg per day for \\>= 75 kg).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \\< 75 kg and 1,200 mg per day for \\>= 75 kg).'}], 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000', 'lowerLimit': '46.0', 'upperLimit': '78.2'}, {'value': '26.4', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '38.1'}, {'value': '33.3', 'groupId': 'OG002', 'lowerLimit': '13.3', 'upperLimit': '59.0'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'IL28B Genotypes (CC, CT or TT)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Participants without measurement at the end of the 24 week untreated follow-up period were considered as non-responders.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 72', 'description': 'Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at Baseline (Week 0).'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Incidence of Anemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants were administered peginterferon alfa-2a 180 mcg SC weekly, 48 weeks and Ribavirin 1,000 mg per day for \\< 75 kg and 1,200 mg per day for \\>= 75 kg, orally daily, 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000', 'lowerLimit': '58.6', 'upperLimit': '75.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 72', 'description': 'Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb \\< 11 gram per decilitre (g/dL) for women and Hb \\< 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who received at least one dose of any study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\\<) 75 kg and 1,200 mg per day for greater than or equal to \\[\\>=\\] 75 kg).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \\< 75 kg and 1,200 mg per day for \\>= 75 kg).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \\< 75 kg and 1,200 mg per day for \\>= 75 kg).'}], 'classes': [{'title': 'RVR rate, Week 4 (n = 14)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'pEVR rate, Week 12 (n = 33)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'cEVR rate, Week 12 (n = 72)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'VR rate, Week 24 (n = 87)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'VR rate, EOT (Week 48) (n = 74)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'VR rate, 12 weeks post-treatment (n = 50)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'SVR rate, 24 weeks or more post-treatment (n = 49)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 12, 24, 48, 60 and 72', 'description': 'Viral Response rate (rapid/early/end of treatment) in relation to IL28-B expression (measured by the rate of non-detection of HCV RNA at treatment Weeks 4, 12, 24 and after the End of Treatment (EOT, i.e. Week 48) based on the expression profile of IL-28B (CC, CT or TT) were reported. Rapid virologic response (RVR) was defined as undetectable HCV RNA at treatment Week 4. Partial early virological response (pEVR) was defined as positive HCV viral load, but with a \\>= 2 log10 international units (IU) per millilitre (mL) reduction at treatment Week 12 from Baseline (Week 0); Complete early virologic response (cEVR) was defined as undetectable HCV RNA at treatment Week 12; Virologic response at treatment Week 24 (VR 24) was defined as undetectable HCV RNA at treatment Week 24; Virologic response at end of treatment (EOT) was defined as undetectable HCV RNA at treatment Week 48; SVR at 24 weeks after end of treatment was defined as undetectable HCV RNA at 24 weeks after EOT.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\\<) 75 kg and 1,200 mg per day for greater than or equal to \\[\\>=\\] 75 kg).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \\< 75 kg and 1,200 mg per day for \\>= 75 kg).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \\< 75 kg and 1,200 mg per day for \\>= 75 kg).'}], 'classes': [{'title': 'SVR with No anemia (n = 15, 20, 6)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'In the first month of treatment (n = 10, 15, 2)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'After the first month of treatment (n = 13, 37,10)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '0.69', 'ciUpperLimit': '4.14', 'estimateComment': 'Odds Ratio for SVR estimated from the logistic regression model.', 'groupDescription': 'Anemia after the first month of treatment vs No anemia', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.28', 'ciUpperLimit': '2.59', 'estimateComment': 'Odds Ratio for SVR estimated from the logistic regression model.', 'groupDescription': 'Anemia in the first month of treatment vs No anemia', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.45', 'ciLowerLimit': '2.27', 'ciUpperLimit': '13.12', 'estimateComment': 'Odds Ratio for SVR estimated from the logistic regression model.', 'groupDescription': 'IL28B - CC vs CT', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.03', 'ciLowerLimit': '1.19', 'ciUpperLimit': '13.61', 'estimateComment': 'Odds Ratio for SVR estimated from the logistic regression model.', 'groupDescription': 'IL28B - CC vs TT', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 72', 'description': 'Participants with sustained virological response (SVR) and development of anemia during the first month and after the first month of treatment according to the different expression profiles of IL-28B were reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\\<) 75 kg and 1,200 mg per day for greater than or equal to \\[\\>=\\] 75 kg).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \\< 75 kg and 1,200 mg per day for \\>= 75 kg).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \\< 75 kg and 1,200 mg per day for \\>= 75 kg).'}], 'classes': [{'title': 'Week 0 - Week 4 (<1.0 log10 UI / ml)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Week 0 - Week 4 (>=1.0 e < 2.0 log10 UI / ml)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Week 0 - Week 4 (>=2.0 e < 3.0 log10 UI / ml)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 0 - Week 4 (>=3.0 e < 4.0 log10 UI / ml)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 0 - Week 4 (>=4.0 log10 UI / ml)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 0 - Week 12 (<1.0 log10 UI / ml)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 0 - Week 12 (>=1.0 e < 2.0 log10 UI / ml)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Week 0 - Week 12 (>=2.0 e < 3.0 log10 UI / ml)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 0 - Week 12 (>=3.0 e < 4.0 log10 UI / ml)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 0 - Week 12 (>=4.0 log10 UI / ml)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline (Week 0) to Week 12', 'description': 'Viral load reduction at Week 4 and Week 12 relative to the Baseline (Week 0) in terms of the expression profile of IL-28b was reported. The reduction was measured according to the following ranges: \\< 1.0 log IU/ml; \\>= 1.0 and \\< 2.0 log IU/ml; \\>= 2.0 and \\< 3.0 log IU/ml; \\>= 3.0 and \\<4.0 log IU/ml; \\>= 4.0 log IU/ml. Changes in viral load are usually reported as a log change (in powers of 10). For example, a two log decrease in viral load (2 Log10) is a decrease of 10\\^2 or 100 times to the previously reported levels. N = number of participants, for Week 0 to Week 4 (n = 34, 68, 17) and Week 0 to Week 12 (n = 35, 69, 18) for CC, CT and TT genotypes respectively.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline. Participants with available data at the time of evaluation were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\\<) 75 kg and 1,200 mg per day for greater than or equal to \\[\\>=\\] 75 kg).'}, {'id': 'FG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \\< 75 kg and 1,200 mg per day for \\>= 75 kg).'}, {'id': 'FG002', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \\< 75 kg and 1,200 mg per day for \\>= 75 kg).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'A total of 129 participants were enrolled from February 2011 to November 2012 at 14 study sites in Brazil.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (\\<) 75 kg and 1,200 mg per day for greater than or equal to \\[\\>=\\] 75 kg).'}, {'id': 'BG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered with peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \\< 75 kg and 1,200 mg per day for \\>= 75 kg).'}, {'id': 'BG002', 'title': 'Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT', 'description': 'Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for \\< 75 kg and 1,200 mg per day for \\>= 75 kg).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.51', 'spread': '12.71', 'groupId': 'BG000'}, {'value': '50.43', 'spread': '10.92', 'groupId': 'BG001'}, {'value': '52.33', 'spread': '10.22', 'groupId': 'BG002'}, {'value': '50.12', 'spread': '11.38', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all enrolled participants who received at least one dose of any study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-24', 'studyFirstSubmitDate': '2011-10-04', 'resultsFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2011-10-04', 'lastUpdatePostDateStruct': {'date': '2016-07-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-18', 'studyFirstPostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression', 'timeFrame': 'At Week 72', 'description': 'Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders.'}, {'measure': 'Percentage of Participants With Incidence of Anemia', 'timeFrame': 'Up to Week 72', 'description': 'Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb \\< 11 gram per decilitre (g/dL) for women and Hb \\< 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression', 'timeFrame': 'Weeks 4, 12, 24, 48, 60 and 72', 'description': 'Viral Response rate (rapid/early/end of treatment) in relation to IL28-B expression (measured by the rate of non-detection of HCV RNA at treatment Weeks 4, 12, 24 and after the End of Treatment (EOT, i.e. Week 48) based on the expression profile of IL-28B (CC, CT or TT) were reported. Rapid virologic response (RVR) was defined as undetectable HCV RNA at treatment Week 4. Partial early virological response (pEVR) was defined as positive HCV viral load, but with a \\>= 2 log10 international units (IU) per millilitre (mL) reduction at treatment Week 12 from Baseline (Week 0); Complete early virologic response (cEVR) was defined as undetectable HCV RNA at treatment Week 12; Virologic response at treatment Week 24 (VR 24) was defined as undetectable HCV RNA at treatment Week 24; Virologic response at end of treatment (EOT) was defined as undetectable HCV RNA at treatment Week 48; SVR at 24 weeks after end of treatment was defined as undetectable HCV RNA at 24 weeks after EOT.'}, {'measure': 'Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment', 'timeFrame': 'Up to Week 72', 'description': 'Participants with sustained virological response (SVR) and development of anemia during the first month and after the first month of treatment according to the different expression profiles of IL-28B were reported.'}, {'measure': 'Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12', 'timeFrame': 'From Baseline (Week 0) to Week 12', 'description': 'Viral load reduction at Week 4 and Week 12 relative to the Baseline (Week 0) in terms of the expression profile of IL-28b was reported. The reduction was measured according to the following ranges: \\< 1.0 log IU/ml; \\>= 1.0 and \\< 2.0 log IU/ml; \\>= 2.0 and \\< 3.0 log IU/ml; \\>= 3.0 and \\<4.0 log IU/ml; \\>= 4.0 log IU/ml. Changes in viral load are usually reported as a log change (in powers of 10). For example, a two log decrease in viral load (2 Log10) is a decrease of 10\\^2 or 100 times to the previously reported levels. N = number of participants, for Week 0 to Week 4 (n = 34, 68, 17) and Week 0 to Week 12 (n = 35, 69, 18) for CC, CT and TT genotypes respectively.'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': "This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/=18 and \\<70 years of age at initiation of treatment\n* Body weight between 50 kg and 125 kg at baseline\n* Chronic hepatitis C, genotype 1\n* Chronic liver disease consistent with HCV infection\n* Compensated liver disease (Child-Pugh Grade A)\n\nExclusion Criteria:\n\n* Pregnant or lactating women, and male partners of pregnant women\n* Chronic hepatitis C, genotype 2, 3, 4, 5 or 6\n* Previous treatment with interferon or ribavirin\n* Positive for hepatitis A, hepatitis B or HIV infection\n* History or evidence of a medical condition associated with liver disease other than chronic hepatitis C\n* Decompensated liver disease and/or liver disease Child-Pugh classification \\>6\n* Hepatocellular carcinoma\n* History or evidence of esophageal bleeding\n* Hemoglobinopathy, or any other cause for possible hemolysis\n* Hb \\<11 g/dL in women, \\<12 g/L in males'}, 'identificationModule': {'nctId': 'NCT01447420', 'briefTitle': 'A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Clinical Trial Comparing the Sustained Virological Response in Terms of Expression Profile of IL- 28B in Genotype 1 HCV-Infected Treatment-Naïve Subjects With Chronic Hepatitis C on Pegasys® (Peginterferon Alfa-2A) Plus Copegus® (Ribavirin)', 'orgStudyIdInfo': {'id': 'ML25592'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peginterferon Alfa-2a Plus Ribavirin', 'interventionNames': ['Drug: peginterferon alfa-2a', 'Drug: ribavirin [Copegus]']}], 'interventions': [{'name': 'peginterferon alfa-2a', 'type': 'DRUG', 'description': '180 mcg sc weekly, 48 weeks', 'armGroupLabels': ['Peginterferon Alfa-2a Plus Ribavirin']}, {'name': 'ribavirin [Copegus]', 'type': 'DRUG', 'description': "1'000 or 1'200 mg orally daily, 48 weeks", 'armGroupLabels': ['Peginterferon Alfa-2a Plus Ribavirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29043-260', 'city': 'Vitória', 'state': 'Espírito Santo', 'country': 'Brazil', 'geoPoint': {'lat': -20.31944, 'lon': -40.33778}}, {'zip': '41110-170', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '36038-330', 'city': 'Juiz de Fora', 'state': 'Minas Gerais', 'country': 'Brazil', 'geoPoint': {'lat': -21.76417, 'lon': -43.35028}}, {'zip': '20020-022', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '20270-004', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '89202-050', 'city': 'Joinville', 'state': 'Santa Catarina', 'country': 'Brazil', 'geoPoint': {'lat': -26.30444, 'lon': -48.84556}}, {'zip': '15090-000', 'city': 'Sao Jose Do Rio Preto', 'state': 'Santa Catarina', 'country': 'Brazil'}, {'zip': '18600-400', 'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'zip': '13026-210', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '13060-803', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '11015470', 'city': 'Santos', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.96083, 'lon': -46.33361}}, {'zip': '04040-003', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04119-001', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04266-010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '18047-600', 'city': 'Sorocaba', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.50167, 'lon': -47.45806}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}