Viewing Study NCT01753557

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Ignite Creation Date: 2025-12-24 @ 6:47 PM
Ignite Modification Date: 2025-12-30 @ 8:39 AM
Study NCT ID: NCT01753557
Status: COMPLETED
Last Update Posted: 2016-10-03
First Post: 2012-12-13
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed 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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cti-inq-ml@ml.mt-pharma.co.jp', 'title': 'Clinical Trials, Information Desk', 'organization': 'Mitsubishi Tanabe Pharma Corporation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment-Naive', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks', 'otherNumAtRisk': 35, 'otherNumAffected': 35, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment-Relapsed', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks', 'otherNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 10}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 12}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 14}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 13}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 6}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 5}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hyaluronic acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Enterocolitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lipid metabolism disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Depressive symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Glossitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Palmoplantar keratoderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dyshidrotic eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-Naive', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}, {'id': 'OG001', 'title': 'Treatment-Relapsed', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '69.7', 'upperLimit': '95.2'}, {'value': '94.7', 'groupId': 'OG001', 'lowerLimit': '74.0', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'unitOfMeasure': 'percentage of subjects achieving SVR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-Naive', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}, {'id': 'OG001', 'title': 'Treatment-Relapsed', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000', 'lowerLimit': '73.3', 'upperLimit': '96.8'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '82.4', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'unitOfMeasure': 'percentage of subjects achieving RVR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-Naive', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}, {'id': 'OG001', 'title': 'Treatment-Relapsed', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '82.4', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'unitOfMeasure': 'percentage of subjects achieving ETR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-Naive', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}, {'id': 'OG001', 'title': 'Treatment-Relapsed', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '82.9', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '93.4'}, {'value': '94.7', 'groupId': 'OG001', 'lowerLimit': '74.0', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 weeks', 'unitOfMeasure': 'percentage of subjects achieving SVR12', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Transition of Serum HCV RNA Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-Naive', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}, {'id': 'OG001', 'title': 'Treatment-Relapsed', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}], 'classes': [{'title': 'baseline (n=35,19)', 'categories': [{'measurements': [{'value': '6.70', 'groupId': 'OG000', 'lowerLimit': '6.30', 'upperLimit': '7.15'}, {'value': '7.05', 'groupId': 'OG001', 'lowerLimit': '6.30', 'upperLimit': '7.30'}]}]}, {'title': 'Day2 (n=35,19)', 'categories': [{'measurements': [{'value': '3.80', 'groupId': 'OG000', 'lowerLimit': '3.60', 'upperLimit': '4.20'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '3.70', 'upperLimit': '4.30'}]}]}, {'title': 'Day3 (n=35,19)', 'categories': [{'measurements': [{'value': '3.10', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '3.50'}, {'value': '3.30', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '3.50'}]}]}, {'title': '1Weeks (n=35,19)', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.60', 'upperLimit': '2.50'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.70', 'upperLimit': '2.50'}]}]}, {'title': '2Weeks (n=34,19)', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '1.30'}]}]}, {'title': '3Weeks (n=35,19)', 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '1.00'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '1.00'}]}]}, {'title': '4Weeks (n=35,19)', 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '0.50'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '0.50'}]}]}, {'title': 'End of treatment (n=35,19)', 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '0.50'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '0.50'}]}]}, {'title': 'Follow-up 12Weeks (n=33,19)', 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '0.50'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '0.50'}]}]}, {'title': 'Follow-up 24Weeks (n=35,19)', 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '0.50'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '0.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks', 'unitOfMeasure': 'log IU/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-Naïve', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}, {'id': 'OG001', 'title': 'Treatment-Relapsed', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}], 'classes': [{'title': 'V36A', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'T54A', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Not detected', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to 24 weeks after completion of drug administration', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment-Naive', 'description': 'Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}, {'id': 'FG001', 'title': 'Treatment-Relapsed', 'description': 'Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment-Naive', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}, {'id': 'BG001', 'title': 'Treatment-Relapsed', 'description': 'Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '54.3', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '52.6', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-09', 'studyFirstSubmitDate': '2012-12-13', 'resultsFirstSubmitDate': '2016-06-14', 'studyFirstSubmitQcDate': '2012-12-17', 'lastUpdatePostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-09', 'studyFirstPostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)', 'timeFrame': '4 weeks'}, {'measure': 'Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)', 'timeFrame': '24 weeks'}, {'measure': 'Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration', 'timeFrame': '36 weeks'}, {'measure': 'Transition of Serum HCV RNA Levels', 'timeFrame': 'baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks'}, {'measure': 'Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)', 'timeFrame': 'From baseline to 24 weeks after completion of drug administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pegasys'], 'conditions': ['Chronic Hepatitis C (CHC)']}, 'referencesModule': {'references': [{'pmid': '27062488', 'type': 'RESULT', 'citation': 'Kumada H, Suzuki F, Kamiya N, Orihashi M, Nakayasu Y, Yamada I. Efficacy and safety of telaprevir with pegylated interferon alpha-2a and ribavirin in Japanese patients. Hepatol Res. 2017 May;47(6):514-521. doi: 10.1111/hepr.12722. Epub 2016 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Genotype 1 CHC\n* treatment-naïve or relapsers (patient who relapsed after previous treatment)\n* Able and willing to follow contraception requirements\n\nExclusion Criteria:\n\n* Cirrhosis of the liver or hepatic failure\n* Hepatitis B surface antigen-positive or HIV (Human Immunodeficiency Virus) antibodies-positive\n* History of, or concurrent hepatocellular carcinoma\n* History of, or concurrent depression, schizophrenia, or suicide attempt in the past\n* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant'}, 'identificationModule': {'nctId': 'NCT01753557', 'briefTitle': 'Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Phase 3 Study of MP-424 in Combination With PEG-IFN Alfa-2a and RBV, in Subjects With Genotype 1 Hepatitis C, Who Are Treatment-Naïve or Relapsed After Previous Treatment', 'orgStudyIdInfo': {'id': 'G060-A12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment-Naive', 'interventionNames': ['Drug: MP-424', 'Drug: RBV', 'Drug: PEG-IFN alfa-2a']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment-Relapsed', 'interventionNames': ['Drug: MP-424', 'Drug: RBV', 'Drug: PEG-IFN alfa-2a']}], 'interventions': [{'name': 'MP-424', 'type': 'DRUG', 'description': 'MP-424: 750mg every 8 hours (q8h) for 12 weeks', 'armGroupLabels': ['Treatment-Naive', 'Treatment-Relapsed']}, {'name': 'RBV', 'type': 'DRUG', 'description': 'RBV: 600 - 1000 mg/day based on body weight for 24 weeks', 'armGroupLabels': ['Treatment-Naive', 'Treatment-Relapsed']}, {'name': 'PEG-IFN alfa-2a', 'type': 'DRUG', 'description': 'PEG-IFN alfa-2a: 180mcg/week for 24 weeks', 'armGroupLabels': ['Treatment-Naive', 'Treatment-Relapsed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '213-8587', 'city': 'Kawasaki', 'state': 'Takatsu-ku', 'country': 'Japan', 'facility': 'Toranomon Hospital', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}], 'overallOfficials': [{'name': 'Kazuoki Kondo, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}