Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-03-03 @ 12:34 AM
Study NCT ID:
NCT03002818
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2016-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Quality of Life Measurement in Treatment Naïve Patients With Hepatitis C Virus (HCV) Genotype 1 (GT1) Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir and Dasabuvir (Viekirax®/Exviera®)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'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': 'From first dose of study drug up to Day 168', 'eventGroups': [{'id': 'EG000', 'title': 'HCV Genotype 1 Participants', 'description': 'Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 9, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline at Day 168 in Mean Daytime Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HCV Genotype 1 Participants', 'description': 'Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)'}], 'classes': [{'title': 'Change at Day 168: sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-108266', 'spread': '313859', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 168: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-98373', 'spread': '325138', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.091', 'groupIds': ['OG000'], 'paramType': 'mean change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-108266', 'ciLowerLimit': '-235037', 'ciUpperLimit': '18504', 'groupDescription': 'sdITT (n=26): Change at Day 168 minus Baseline', 'statisticalMethod': 'one-sample t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.152', 'groupIds': ['OG000'], 'paramType': 'mean change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-98373', 'ciLowerLimit': '-235667', 'ciUpperLimit': '38921', 'groupDescription': 'mITT (n=24): Change at Day 168 minus Baseline', 'statisticalMethod': 'one-sample t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.091', 'groupIds': ['OG000'], 'groupDescription': 'sdITT (n=26): Baseline vs. Day 168', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.152', 'groupIds': ['OG000'], 'groupDescription': 'mITT (n=24): Baseline vs. Day 168', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 168', 'description': 'Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.', 'unitOfMeasure': 'day-counts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Mean Daytime Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HCV Genotype 1 Participants', 'description': 'Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)'}], 'classes': [{'title': 'Change at Day 28: sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26990', 'spread': '211108', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 28: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21422', 'spread': '215104', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 84: sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6448', 'spread': '198441', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 84: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13020', 'spread': '197825', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 168: sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-108266', 'spread': '313859', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 168: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-98373', 'spread': '325138', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.461', 'groupIds': ['OG000'], 'groupDescription': 'sdITT (n=34): Baseline vs. Day 28', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.630', 'groupIds': ['OG000'], 'groupDescription': 'mITT (n=24): Baseline vs. Day 28', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.855', 'groupIds': ['OG000'], 'groupDescription': 'sdITT (n=32): Baseline vs. Day 84', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.750', 'groupIds': ['OG000'], 'groupDescription': 'mITT (n=24): Baseline vs. Day 84', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.', 'unitOfMeasure': 'day-counts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HCV Genotype 1 Participants', 'description': 'Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)'}], 'classes': [{'title': 'Change at Day 28: sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.69', 'spread': '1.01', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 28: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.85', 'spread': '1.06', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 84: sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.68', 'spread': '1.54', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 84: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.76', 'spread': '1.64', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 168: sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.60', 'spread': '1.62', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 168: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.82', 'spread': '1.52', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'mean change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.60', 'ciLowerLimit': '2.063', 'ciUpperLimit': '3.137', 'groupDescription': 'sdITT: mean change Baseline minus Day 168', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'mean change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.82', 'ciLowerLimit': '2.212', 'ciUpperLimit': '3.428', 'groupDescription': 'mITT: mean change Baseline minus Day 168', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'sdITT (n=37): Baseline vs. Day 168', 'statisticalMethod': 'Paired Wilcoxon Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'mITT (n=24): Baseline vs. Day 168', 'statisticalMethod': 'Paired Wilcoxon Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'sdITT (n=35): Baseline vs. Day 28', 'statisticalMethod': 'Paired Wilcoxon Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'mITT (n=22): Baseline vs. Day 28', 'statisticalMethod': 'Paired Wilcoxon Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'sdITT (n=36): Baseline vs. Day 84', 'statisticalMethod': 'Paired Wilcoxon Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'mITT (n=23): Baseline vs. Day 84', 'statisticalMethod': 'Paired Wilcoxon Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'The FSS is a 9-item questionnaire assessing the functional impact of fatigue during the past two weeks on multiple life domains using scales from 1 (strongly disagree) to 7 (strongly agree). The fatigue score is the mean score of the 9 items, with lower scores indicating less fatigue severity. Clinically significant fatigue is usually defined as score equal or above 4. Changes were calculated by the formula "Baseline minus Day 28, Day 84, or Day 168." Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Sleep Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HCV Genotype 1 Participants', 'description': 'Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)'}], 'classes': [{'title': 'Change at Day 28: sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.87', 'spread': '2.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 28: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.44', 'spread': '2.68', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 84: sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '2.81', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 84: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '2.98', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 168: sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '3.28', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 168: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.74', 'spread': '3.37', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'mean change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '-0.651', 'ciUpperLimit': '1.871', 'groupDescription': 'sdITT: mean change Baseline minus Day 168', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000'], 'paramType': 'mean change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '-0.608', 'ciUpperLimit': '2.088', 'groupDescription': 'mITT: mean change Baseline minus Day 168', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.381', 'groupIds': ['OG000'], 'groupDescription': 'sdITT (n=37): Baseline vs. Day 168', 'statisticalMethod': 'Paired Wilcoxon Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.304', 'groupIds': ['OG000'], 'groupDescription': 'mITT (n=24): Baseline vs. Day 168', 'statisticalMethod': 'Paired Wilcoxon Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.014', 'groupIds': ['OG000'], 'groupDescription': 'sdITT (n=35): Baseline vs. Day 28', 'statisticalMethod': 'Paired Wilcoxon Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.278', 'groupIds': ['OG000'], 'groupDescription': 'mITT (n=22): Baseline vs. Day 28', 'statisticalMethod': 'Paired Wilcoxon Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.881', 'groupIds': ['OG000'], 'groupDescription': 'sdITT (n=36): Baseline vs. Day 84', 'statisticalMethod': 'Paired Wilcoxon Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.775', 'groupIds': ['OG000'], 'groupDescription': 'sdITT (n=23): Baseline vs. Day 84', 'statisticalMethod': 'Paired Wilcoxon Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'Sleep efficiency for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link). Sleep efficiency was defined as the percent of time scored as sleep during the sleep period, from 0% to 100%. Changes were calculated by the formula "Baseline minus Day 28, Day 84, or Day 168." Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement.', 'unitOfMeasure': 'percent of time asleep', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HCV Genotype 1 Participants', 'description': 'Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.300', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0.131', 'groupId': 'OG000'}]}]}, {'title': 'Day 84', 'categories': [{'measurements': [{'value': '-0.022', 'groupId': 'OG000'}]}]}, {'title': 'Day 168', 'categories': [{'measurements': [{'value': '0.195', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.', 'unitOfMeasure': 'Spearman correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HCV Genotype 1 Participants', 'description': 'Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.253', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0.386', 'groupId': 'OG000'}]}]}, {'title': 'Day 84', 'categories': [{'measurements': [{'value': '-0.058', 'groupId': 'OG000'}]}]}, {'title': 'Day 168', 'categories': [{'measurements': [{'value': '0.128', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.', 'unitOfMeasure': 'Spearman correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HCV Genotype 1 Participants', 'description': 'Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)'}], 'classes': [{'title': 'Baseline minus Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.228', 'groupId': 'OG000'}]}]}, {'title': 'Baseline minus Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.044', 'groupId': 'OG000'}]}]}, {'title': 'Baseline minus Day 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.195', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.', 'unitOfMeasure': 'Spearman correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HCV Genotype 1 Participants', 'description': 'Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)'}], 'classes': [{'title': 'Baseline minus Day 28', 'categories': [{'measurements': [{'value': '0.135', 'groupId': 'OG000'}]}]}, {'title': 'Baseline minus Day 84', 'categories': [{'measurements': [{'value': '-0.065', 'groupId': 'OG000'}]}]}, {'title': 'Baseline minus Day 168', 'categories': [{'measurements': [{'value': '0.169', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.', 'unitOfMeasure': 'Spearman correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HCV Genotype 1 Participants', 'description': 'Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)'}], 'classes': [{'title': 'ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '100'}]}]}, {'title': 'sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000', 'lowerLimit': '92.3', 'upperLimit': '100'}]}]}, {'title': 'mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '88.3', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 168 (or 12 weeks after the last dose of study drug)', 'description': 'SVR12 defined as hepatitis C virus ribonucleic acid (HCV RNA) not detectable 12 weeks after the last actual dose of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hepatitis C Virus (HCV) Genotype 1 Participants', 'description': 'Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'eligible participants who received 3D regimen at least once', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Decision of the investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HCV Genotype 1 Participants', 'description': 'Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49.4', 'spread': '12.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mean Daytime Physical Activity', 'classes': [{'title': 'sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1469569', 'spread': '405329', 'groupId': 'BG000'}]}]}, {'title': 'mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1513166', 'spread': '410686', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.', 'unitOfMeasure': 'day-counts', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Intent to treat (ITT) population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets.'}, {'title': 'Fatigue Severity Scale (FSS)', 'classes': [{'title': 'sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.95', 'spread': '0.61', 'groupId': 'BG000'}]}]}, {'title': 'mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.94', 'spread': '0.67', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'description': 'The FSS is a nine-item questionnaire assessing the functional impact of fatigue during the past two weeks on multiple life domains using scales from 1 (strongly disagree) to 7 (strongly agree). The fatigue score is the mean score of the 9 items, with lower scores indicating less fatigue severity. Clinically significant fatigue is usually defined as score equal or above 4.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Intent to treat (ITT) population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets.'}, {'title': 'Sleep Efficiency', 'classes': [{'title': 'sdITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '89.4', 'spread': '4.58', 'groupId': 'BG000'}]}]}, {'title': 'mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '89.8', 'spread': '3.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Sleep efficiency for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link). Sleep efficiency was defined as the percent of time scored as sleep during the sleep period, from 0% to 100%.', 'unitOfMeasure': 'percent of time asleep', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Intent to treat (ITT) population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-20', 'size': 1302058, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-09-23T09:56', 'hasProtocol': True}, {'date': '2018-02-05', 'size': 1237753, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-09-23T09:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-30', 'studyFirstSubmitDate': '2016-12-15', 'resultsFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2016-12-21', 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-30', 'studyFirstPostDateStruct': {'date': '2016-12-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline at Day 168 in Mean Daytime Physical Activity', 'timeFrame': 'Baseline, Day 168', 'description': 'Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline Over Time in Mean Daytime Physical Activity', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.'}, {'measure': 'Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'The FSS is a 9-item questionnaire assessing the functional impact of fatigue during the past two weeks on multiple life domains using scales from 1 (strongly disagree) to 7 (strongly agree). The fatigue score is the mean score of the 9 items, with lower scores indicating less fatigue severity. Clinically significant fatigue is usually defined as score equal or above 4. Changes were calculated by the formula "Baseline minus Day 28, Day 84, or Day 168." Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement.'}, {'measure': 'Change From Baseline Over Time in Sleep Efficiency', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'Sleep efficiency for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link). Sleep efficiency was defined as the percent of time scored as sleep during the sleep period, from 0% to 100%. Changes were calculated by the formula "Baseline minus Day 28, Day 84, or Day 168." Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement.'}, {'measure': 'Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.'}, {'measure': 'Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.'}, {'measure': 'Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.'}, {'measure': 'Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population', 'timeFrame': 'Baseline, Days 28, 84, 168', 'description': 'The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.'}, {'measure': 'Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment', 'timeFrame': 'Day 168 (or 12 weeks after the last dose of study drug)', 'description': 'SVR12 defined as hepatitis C virus ribonucleic acid (HCV RNA) not detectable 12 weeks after the last actual dose of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Hepatitis C (HCV)', 'Genotype 1', 'Paritaprevir', 'Ritonavir', 'ombitasvir', 'Dasabuvir', 'Sustained Virological Response'], 'conditions': ['Chronic Hepatitis C Virus (HCV)']}, 'referencesModule': {'references': [{'pmid': '33147283', 'type': 'DERIVED', 'citation': 'Semmo N, Mullhaupt B, Ruckstuhl L, Magenta L, Clerc O, Torgler R, Semela D. A prospective, multicenter, post-marketing observational study to measure the quality of life of HCV genotype 1 infected, treatment naive patients suffering from fatigue and receiving 3D regimen: The HEMATITE study. PLoS One. 2020 Nov 4;15(11):e0241267. doi: 10.1371/journal.pone.0241267. eCollection 2020.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is an observational, prospective, open-label, single-arm, multicenter, real-life study designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen) on total daytime physical activity and fatigue in participants with HCV GT1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with CHC, genotype 1, receiving paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (3D regimen)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Treatment-naïve participants\n* Mono-infected participants with chronic HCV GT1\n* Non-cirrhotic participants\n* Participants with debilitating fatigue (Fatigue Severity Scale \\[FSS\\] greater than or equal to 4)\n\nExclusion Criteria:\n\n* Participants with sources of fatigue other than HCV (especially, severe depression, cancer and hormonal disorders causing clinically significant fatigue)\n* Participants with conditions that do not allow to adhere to protocol and use of the device at investigator's discretion\n* Participants who are wheelchair dependent"}, 'identificationModule': {'nctId': 'NCT03002818', 'acronym': 'HEMATITE', 'briefTitle': 'Quality of Life Measurement in Treatment Naïve Patients With Hepatitis C Virus (HCV) Genotype 1 (GT1) Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir and Dasabuvir (Viekirax®/Exviera®)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Quality of Life Measurement Using Wrist Actigraphy in HCV Genotype 1 Infected, Treatment naïve Patients Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir Tablets and Dasabuvir Tablets (Viekirax®/Exviera®; 3D Regimen): The HEMATITE Study', 'orgStudyIdInfo': {'id': 'P16-272'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCV Genotype 1 Participants', 'description': 'Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9007', 'city': 'Sankt Gallen', 'state': 'Canton of St. Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital, Universitaetsklin', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '6900', 'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Fondazione Epatocentro Ticino', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'zip': 'CH-2000', 'city': 'Neuchâtel', 'country': 'Switzerland', 'facility': 'Hopital Neuchatelois', 'geoPoint': {'lat': 46.99179, 'lon': 6.931}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitaetsspital Zuerich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}