Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-04-08 @ 7:26 AM
Study NCT ID:
NCT02582658
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2015-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).', 'description': 'TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir', 'otherNumAtRisk': 171, 'otherNumAffected': 27, 'seriousNumAtRisk': 171, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hepatocellular Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Chronic Kidney Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.8', 'groupId': 'OG000', 'lowerLimit': '78.6', 'upperLimit': '89.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Weeks after the last dose of study drug', 'description': 'SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \\< 50 IU/mL 12 weeks after the last actual dose of study drug.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core Population (CP) was defined as all patients in the safety population (SP; all enrolled subjects who received at least 1 dose of study drug) who met eligibility criteria and were adequately treated according to the standard of care and within local label recommendations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virological Response at End of Treatment (EoTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000', 'lowerLimit': '90.0', 'upperLimit': '97.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks of treatment', 'description': 'The percentage of participants with virological response (HCV RNA \\<50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin \\[RBV\\]).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Core Population (CP)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With On-treatment Virologic Failure (Breakthrough)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 24 weeks', 'description': 'The percentage of participants with on-treatment virologic failure (breakthrough \\[defined as at least one documented HCV RNA \\<50 IU/mL followed by HCV RNA \\>= 50 IU/mL during treatment\\]).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core Population (CP)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '91.3', 'upperLimit': '98.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after last dose of study drug', 'description': 'SVR12 is defined as HCV RNA levels \\< 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'CP subjects with evaluable HCV RNA data ≥70 days after last dose AbbVie Regimen, or HCV RNA value ≥50IU/mL at last measurement postbaseline, or HCV RNA \\<50IU /mL at last measurement postbaseline, but no HCV RNA value ≥70 days after last dose AbbVie Regimen due to safety or virologic failure (relapse reported but date/value of HCV RNA test missing).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Post-treatment Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 weeks after last dose of study drug', 'description': 'The percentage of participants with relapse (defined as HCV RNA \\<50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core Population (CP)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Planned Duration of Ribavirin (RBV) Taken', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.7', 'spread': '16.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 weeks of treatment', 'description': 'Adherence to RBV is defined as percentage of target dose (adherence=cumulated dose taken/ \\[initially prescribed dose x planned duration\\]).', 'unitOfMeasure': 'percentage of planned RBV dose taken', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Core Population (CP) who received RBV'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Score of Participant Activation According to the Patient Activation Measure (PAM-13) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'title': 'PAM-13 Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.3', 'spread': '10.9', 'groupId': 'OG000'}]}]}, {'title': 'PAM-13 EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.6', 'spread': '10.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and End of Treatment (EoT)', 'description': 'The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4. The responses to the 13 questions are summed and transformed into a PAM Score between 0 and 100; a higher score indicates more knowledge and confidence to take action for self-management.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Core Population (CP)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'title': 'Patients Taking at least 1 co-medication', 'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000'}]}]}, {'title': 'Analgesics', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}]}]}, {'title': 'Antidepressants', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}]}]}, {'title': 'Beta blocking agents', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}]}]}, {'title': 'Calcium channel blockers', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid therapy', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'Vitamins', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'Blood glucose lowering drugs', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}]}]}, {'title': 'Drugs used in addictive disorders', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}]}]}, {'title': 'ACE inhibitors', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Angriotensin II antagonists', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Anti-asthmatics', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Benzodiazepine derivatives', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Antithrombotic', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Drugs for peptic ulcer/gastroesophageal reflux dis', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Angiotensin II Antagonists', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Antipsychotics', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Diuretics', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'ACE inhibitors, combinations', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Insulin and analogues', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Mineral supplements', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Antieplieptics', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Anti-inflammatory and antirheumatic products', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Drugs used in benign prostatic hypertrophy', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Herbal medicine', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Vasodilators for cardiac diseases', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Anti-dementia drugs', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Antibacterials', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Anti-gout preparations', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Drugs for functional gastrointestinal disorders', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'HMG COA reductase inhibitors', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Hypnotics and sedatives', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Immunosuppressive agents', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Lipotropics', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Vasoprotectives', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Anti-adrenergic antihypertensives', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Antibiotics for dermatological use', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Antiemetics and anti nauseants', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Antigloucoma', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Antihistamines', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Antineoplastic/immunomodulating agents, cytostatic', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to end of treatment (up to 24 weeks)', 'description': 'Percentage of participants taking at least 1 concomitant medication', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population (SP) was defined as enrolled patients who received at least 1 dose of ABBVIE REGIMEN.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Co-morbidities and/or Co-infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'title': 'All co-morbidities and co-infections', 'categories': [{'measurements': [{'value': '57.6', 'groupId': 'OG000'}]}]}, {'title': 'HCV co-infections', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Liver and/or CHC related co-morbidities', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}]}]}, {'title': 'Chronic kidney disease', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Psychiatric disorders', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}]}]}, {'title': 'Diabetes mellitus', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}]}]}, {'title': 'Lipid disorder', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}]}]}, {'title': 'Hyperthyroidism', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Hypothyroidism', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}]}]}, {'title': 'Cardiovascular disease', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}]}]}, {'title': 'Immunologically medicated disease', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Psychoactive substance dependency', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'Percentage of participants with co-morbidities and/or co-infections at baseline (Day 0).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core Population (CP)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'title': 'EQ-5D-5L: Index Score Basline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.17', 'groupId': 'OG000'}]}]}, {'title': 'EQ-5D-5L: Index Score 12 Weeks EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': 'EQ-5D-5L: VAS Score Basline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.4', 'spread': '19.5', 'groupId': 'OG000'}]}]}, {'title': 'EQ-5D-5L: VAS Score 12 Weeks EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.4', 'spread': '17.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and post treatment week 12', 'description': "The EQ-5D-5L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. The EQ-5D visual analogue scale (VAS) records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Core Population (CP)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Mean Score From Baseline to 12 Weeks After End of Treatment (EOT) in Work Productivity and Activity Impairment (WPAI) Version 2: Hepatitis C Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'title': 'Change from baseline in absenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline in presenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.6', 'spread': '17.3', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline in total work impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.5', 'spread': '17.2', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline in total activity impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.3', 'spread': '29.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 to post treatment week 12', 'description': 'The WPAI questionnaire was used to measure work absenteeism, work presenteeism, work productivity impairment and daily activity impairment. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity: Presenteeism - percentage of impairment while working due to health problem; Total work productivity impairment - percentage of overall work impairment due to health problem Absenteeism - percentage of work time missed due to health problem; Total activity impairment - percentage of general (non-work) activity impairment due to health problem', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Core Population (CP)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Support Program (PSP) Utilization and Satisfaction Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'title': 'Participants Using at least 1 PSP since last visit', 'categories': [{'measurements': [{'value': '65.4', 'groupId': 'OG000'}]}]}, {'title': 'Personal support - satisfaction Very Good', 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000'}]}]}, {'title': 'Personal support satisfaction - Good', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}]}]}, {'title': 'Personal support satisfaction - Satisfactory', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks of treatment', 'description': "The AbbVie PSP included educational and information material (including printed, online, pillbox), digital and mobile resource (web-portal), digital and mobile resources (reminders). The PSP utilization and satisfaction assessment evaluated the frequency of utilization (usually daily, several times per week, usually once weekly, less than once weekly) and patient's overall satisfaction (very good, good, satisfactory) with their respective PSP.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core Population (CP)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Adherence to Planned RBV Target Dose Taken', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'title': '> 105% Adherence', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}]}]}, {'title': '>95% - <=105% Adherence', 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000'}]}]}, {'title': '>80% - <=95% Adherence', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}, {'title': '>50% - <=80% Adherence', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': '<=50% Adherence', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks of treatment', 'description': 'Adherence to RBV is defined as percentage of target dose (adherence=cumulated number of pills taken / \\[initially prescribed number of pills x planned duration\\]) and categorized as follows: \\>105%, \\>95% - \\<=105%, \\>80% - \\<=95%, \\>50% - \\<=80%, \\<=50%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Core Population (CP) who received RBV'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Deviating From the Target ABBVIE Regimen Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'title': 'Early discontinuation', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}]}]}, {'title': 'Exeedance', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Not deviated', 'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks of treatment', 'description': 'Deviations from the target dose of the ABBVIE REGIMEN were defined as the actual duration is shortened/prolonged (exceedence) for more than 7 days.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core Population (CP)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir.'}], 'classes': [{'title': '> 105% Adherence', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': '>95% - <=105% Adherence', 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000'}]}]}, {'title': '>80% - <=95% Adherence', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}, {'title': '>50% - <=80% Adherence', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}]}]}, {'title': '<=50% Adherence', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks of treatment', 'description': 'Adherence to the ABBVIE REGIMEN was defined as percentage of target dose (adherence=cumulated number of pills taken / \\[initially prescribed number of pills x planned duration\\]) and categorized as follows: \\>105%, \\>95% to \\<=105%, \\>80% to \\<=95%, \\>50% to \\<=80%, \\<=50%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core Population (CP)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Failure to Return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Insufficient Virological Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawn Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Not further specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}], 'preAssignmentDetails': 'A total of 173 patients were enrolled in the study; 2 patients never started treatment and were excluded from the safety (SP; N=171); 6 patients were excluded from the core population (CP; N=165), defined as all SP patients who met eligibility criteria and were adequately treated according to the standard of care and local label recommendations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ABBVIE REGIMEN +/- Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '13.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '115', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasin', 'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}]}]}, {'title': 'Asian/Oriental', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Core Population (CP) was defined as all patients in the safety population (SP; all enrolled subjects who received at least 1 dose of study drug) who met eligibility criteria and were adequately treated according to the standard of care and within local label recommendations.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-28', 'studyFirstSubmitDate': '2015-10-20', 'resultsFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2015-10-20', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-28', 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Planned Duration of Ribavirin (RBV) Taken', 'timeFrame': 'Up to 24 weeks of treatment', 'description': 'Adherence to RBV is defined as percentage of target dose (adherence=cumulated dose taken/ \\[initially prescribed dose x planned duration\\]).'}, {'measure': 'Total Score of Participant Activation According to the Patient Activation Measure (PAM-13) Questionnaire', 'timeFrame': 'Day 0 and End of Treatment (EoT)', 'description': 'The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4. The responses to the 13 questions are summed and transformed into a PAM Score between 0 and 100; a higher score indicates more knowledge and confidence to take action for self-management.'}, {'measure': 'Percentage of Participants With Concomitant Medications', 'timeFrame': 'Day 0 to end of treatment (up to 24 weeks)', 'description': 'Percentage of participants taking at least 1 concomitant medication'}, {'measure': 'Percentage of Participants With Co-morbidities and/or Co-infections', 'timeFrame': 'Day 0', 'description': 'Percentage of participants with co-morbidities and/or co-infections at baseline (Day 0).'}, {'measure': 'Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire', 'timeFrame': 'Day 0 and post treatment week 12', 'description': "The EQ-5D-5L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. The EQ-5D visual analogue scale (VAS) records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement."}, {'measure': 'Change in Mean Score From Baseline to 12 Weeks After End of Treatment (EOT) in Work Productivity and Activity Impairment (WPAI) Version 2: Hepatitis C Questionnaire', 'timeFrame': 'Day 0 to post treatment week 12', 'description': 'The WPAI questionnaire was used to measure work absenteeism, work presenteeism, work productivity impairment and daily activity impairment. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity: Presenteeism - percentage of impairment while working due to health problem; Total work productivity impairment - percentage of overall work impairment due to health problem Absenteeism - percentage of work time missed due to health problem; Total activity impairment - percentage of general (non-work) activity impairment due to health problem'}, {'measure': 'Patient Support Program (PSP) Utilization and Satisfaction Assessment', 'timeFrame': 'Up to 24 weeks of treatment', 'description': "The AbbVie PSP included educational and information material (including printed, online, pillbox), digital and mobile resource (web-portal), digital and mobile resources (reminders). The PSP utilization and satisfaction assessment evaluated the frequency of utilization (usually daily, several times per week, usually once weekly, less than once weekly) and patient's overall satisfaction (very good, good, satisfactory) with their respective PSP."}, {'measure': 'Percentage of Participants With Adherence to Planned RBV Target Dose Taken', 'timeFrame': 'Up to 24 weeks of treatment', 'description': 'Adherence to RBV is defined as percentage of target dose (adherence=cumulated number of pills taken / \\[initially prescribed number of pills x planned duration\\]) and categorized as follows: \\>105%, \\>95% - \\<=105%, \\>80% - \\<=95%, \\>50% - \\<=80%, \\<=50%.'}, {'measure': 'Percentage of Participants Deviating From the Target ABBVIE Regimen Duration', 'timeFrame': 'Up to 24 weeks of treatment', 'description': 'Deviations from the target dose of the ABBVIE REGIMEN were defined as the actual duration is shortened/prolonged (exceedence) for more than 7 days.'}, {'measure': 'Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken', 'timeFrame': 'Up to 24 weeks of treatment', 'description': 'Adherence to the ABBVIE REGIMEN was defined as percentage of target dose (adherence=cumulated number of pills taken / \\[initially prescribed number of pills x planned duration\\]) and categorized as follows: \\>105%, \\>95% to \\<=105%, \\>80% to \\<=95%, \\>50% to \\<=80%, \\<=50%.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)', 'timeFrame': '12 Weeks after the last dose of study drug', 'description': 'SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \\< 50 IU/mL 12 weeks after the last actual dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Virological Response at End of Treatment (EoTR)', 'timeFrame': 'Up to 24 weeks of treatment', 'description': 'The percentage of participants with virological response (HCV RNA \\<50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin \\[RBV\\]).'}, {'measure': 'Percentage of Participants With On-treatment Virologic Failure (Breakthrough)', 'timeFrame': 'Up to approximately 24 weeks', 'description': 'The percentage of participants with on-treatment virologic failure (breakthrough \\[defined as at least one documented HCV RNA \\<50 IU/mL followed by HCV RNA \\>= 50 IU/mL during treatment\\]).'}, {'measure': 'Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)', 'timeFrame': '12 weeks after last dose of study drug', 'description': 'SVR12 is defined as HCV RNA levels \\< 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU).'}, {'measure': 'Percentage of Participants With Post-treatment Relapse', 'timeFrame': 'Up to 12 weeks after last dose of study drug', 'description': 'The percentage of participants with relapse (defined as HCV RNA \\<50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Paritaprevir', 'Dasabuvir', 'Ombitasvir', 'Chronic Hepatitis C', 'HCV'], 'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '30739368', 'type': 'DERIVED', 'citation': 'Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C virus (HCV) infected participants in Austria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic infection of HCV Genotype 1 (GT1) or Genotype 4 (GT4)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTreatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label\n\nIf RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)\n\nPatients must voluntarily sign and date a patient authorization to use and disclose his/her anonymized health data prior to inclusion into the study\n\nPatient must not be participating or intending to participate in a concurrent interventional therapeutic trial\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT02582658', 'acronym': 'REAL', 'briefTitle': 'Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Austria (REAL)', 'orgStudyIdInfo': {'id': 'P15-695'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic infection of HCV GT1 or GT4', 'description': 'Participants with confirmed chronic hepatitis C genotype (GT) 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) ± Ribavirin (RBV) according to standard of care and in line with the current local label'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alexander P Dorr, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie Austria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}