Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-04 @ 4:55 PM
Study NCT ID:
NCT02725866
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2016-03-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece']}, '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': 'C585405', 'term': 'paritaprevir'}, {'id': 'C586094', 'term': 'ombitasvir'}, {'id': 'C588260', 'term': 'dasabuvir'}, {'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': '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 time of study drug administration until 30 days after the last dose of study drug (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 and were collected whether elicited or spontaneously reported by the participant.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants With HCV Genotype 1 or 4', 'description': 'Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks', 'otherNumAtRisk': 216, 'deathsNumAtRisk': 216, 'otherNumAffected': 21, 'seriousNumAtRisk': 216, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Substance use', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Substance use', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With HCV Genotype 1 or 4', 'description': 'Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks'}], 'classes': [{'title': 'Core population (CP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000', 'lowerLimit': '86.5', 'upperLimit': '94.2'}]}]}, {'title': 'CPSFU12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000', 'lowerLimit': '91.8', 'upperLimit': '97.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:\n\n* evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN\n* an HCV RNA value ≥50 IU/mL at the last measurement post-baseline\n* HCV RNA \\<50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population (CP) and core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) are defined in the outcome measure description.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Response at End of Treatment (EoT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With HCV Genotype 1 or 4', 'description': 'Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000', 'lowerLimit': '89.8', 'upperLimit': '96.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'Virologic response was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With HCV Genotype 1 or 4', 'description': 'Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Viral Breakthrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With HCV Genotype 1 or 4', 'description': 'Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '27.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'Viral breakthrough was defined as at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population (those meeting inclusion criteria and treated according to the standard of care and w/in local label guidelines for specific disease characteristics \\[cirrhotic status, genotype\\]) who had at least 1 undetectable or unquantifiable, on-treatment HCV RNA measurement and at least 1 on-treatment or end of treatment measurement thereafter.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With On-treatment Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With HCV Genotype 1 or 4', 'description': 'Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'On-treatment virologic failure was defined as breakthrough (at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting Relapse Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With HCV Genotype 1 or 4', 'description': 'Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With HCV Genotype 1 or 4', 'description': 'Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With HCV Genotype 1 or 4', 'description': 'Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response was documented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With HCV Genotype 1 or 4', 'description': 'Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '216'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Failure to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Insufficient virological response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'Safety population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN. The prescribed ABBVIE REGIMEN needed to be known.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With HCV Genotype 1 or 4', 'description': 'Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '115', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '211', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Hepatitis C genotype', 'classes': [{'categories': [{'title': 'Genotype 1', 'measurements': [{'value': '151', 'groupId': 'BG000'}]}, {'title': 'Genotype 4', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN. The prescribed ABBVIE REGIMEN needed to be known.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-18', 'size': 1954556, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-22T09:36', 'hasProtocol': True}, {'date': '2017-07-28', 'size': 521974, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-22T09:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2016-03-24', 'resultsFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2016-03-29', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-22', 'studyFirstPostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:\n\n* evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN\n* an HCV RNA value ≥50 IU/mL at the last measurement post-baseline\n* HCV RNA \\<50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Virologic Response at End of Treatment (EoT)', 'timeFrame': 'Up to 24 weeks', 'description': 'Virologic response was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.'}, {'measure': 'Percentage of Participants With Relapse', 'timeFrame': 'Up to 24 weeks', 'description': 'Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.'}, {'measure': 'Percentage of Participants With Viral Breakthrough', 'timeFrame': 'Up to 24 weeks', 'description': 'Viral breakthrough was defined as at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.'}, {'measure': 'Percentage of Participants With On-treatment Virologic Failure', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'On-treatment virologic failure was defined as breakthrough (at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL).'}, {'measure': 'Percentage of Participants Meeting Relapse Criteria', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.'}, {'measure': 'Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.'}, {'measure': 'Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response was documented.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Observational Study', 'Sustained Virological Response', 'Chronic Hepatitis C genotype 1', 'Chronic Hepatitis C', 'Ombitasvir/paritaprevir/ritonavir ± dasabuvir', 'Chronic Hepatitis C genotype 4'], '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 interferon-free combination regimen of paritaprevir/ritonavir/ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions.\n\nThis observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to the local label, under real-world conditions in Greece in a clinical practice patient population.', 'detailedDescription': "This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. Adults chronically infected with hepatitis C virus (HCV), receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with treatment duration of 24 weeks), end of treatment (EoT), early post-treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment \\[SVR12\\] and sustained virologic response 24 weeks after the end of treatment \\[SVR24\\])."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with chronic hepatitis C virus infection, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, 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* If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)\n* Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study\n* Participant must not have participated or intended to participate in a concurrent interventional therapeutic trial\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02725866', 'briefTitle': 'Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C - An Observational Study in Greece', 'orgStudyIdInfo': {'id': 'P15-842'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with HCV genotype 1 or 4', 'description': 'Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks', 'interventionNames': ['Drug: Paritaprevir/ritonavir/ombitasvir', 'Drug: Dasabuvir', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Paritaprevir/ritonavir/ombitasvir', 'type': 'DRUG', 'otherNames': ['Paritaprevir also known as ABT-450', 'Ombitasvir also known as ABT-267'], 'description': 'Co-formulated tablet', 'armGroupLabels': ['Participants with HCV genotype 1 or 4']}, {'name': 'Dasabuvir', 'type': 'DRUG', 'otherNames': ['ABT-333'], 'description': 'Tablet', 'armGroupLabels': ['Participants with HCV genotype 1 or 4']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['Participants with HCV genotype 1 or 4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Georgios Mitas, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'AbbVie Pharmaceuticals S.A. (Greece)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}