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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCV Genotype 1 Participants | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Day 168 in Mean Daytime Physical Activity | 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. | Baseline, Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Over Time in Mean Daytime Physical Activity | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with CHC, genotype 1, receiving paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (3D regimen)
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital St. Gallen | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland | ||
| Inselspital, Universitaetsklin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33147283 | Derived | 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. |
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| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hepatitis C Virus (HCV) Genotype 1 Participants | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2016 | Sep 23, 2019 |
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| Baseline, Days 28, 84, 168 |
| Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score | 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. | Baseline, Days 28, 84, 168 |
| Change From Baseline Over Time in Sleep Efficiency | 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. | Baseline, Days 28, 84, 168 |
| Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population | 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. | Baseline, Days 28, 84, 168 |
| Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population | 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. | Baseline, Days 28, 84, 168 |
| Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population | 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. | Baseline, Days 28, 84, 168 |
| Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population | 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. | Baseline, Days 28, 84, 168 |
| Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment | 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). | Day 168 (or 12 weeks after the last dose of study drug) |
| Bern |
| 3010 |
| Switzerland |
| Fondazione Epatocentro Ticino | Lugano | 6900 | Switzerland |
| Hopital Neuchatelois | Neuchâtel | CH-2000 | Switzerland |
| Universitaetsspital Zuerich | Zurich | 8091 | Switzerland |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HCV Genotype 1 Participants | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Mean Daytime Physical Activity | 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. | 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. | Mean | Standard Deviation | day-counts |
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| Fatigue Severity Scale (FSS) | 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. | 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. | Median | Standard Deviation | score on a scale |
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| Sleep Efficiency | 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%. | 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. | Mean | Standard Deviation | percent of time asleep |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline at Day 168 in Mean Daytime Physical Activity | 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. | 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. | Posted | Mean | Standard Deviation | day-counts | Baseline, Day 168 |
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| Secondary | Change From Baseline Over Time in Mean Daytime Physical Activity | 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. | 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. | Posted | Mean | Standard Deviation | day-counts | Baseline, Days 28, 84, 168 |
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| Secondary | Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Days 28, 84, 168 |
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| Secondary | Change From Baseline Over Time in Sleep Efficiency | 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. | 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. | Posted | Mean | Standard Deviation | percent of time asleep | Baseline, Days 28, 84, 168 |
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| Secondary | Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population | 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. | 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. | Posted | Number | Spearman correlation coefficient | Baseline, Days 28, 84, 168 |
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| Secondary | Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population | 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. | 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. | Posted | Number | Spearman correlation coefficient | Baseline, Days 28, 84, 168 |
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| Secondary | Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population | 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. | 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. | Posted | Number | Spearman correlation coefficient | Baseline, Days 28, 84, 168 |
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| Secondary | Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population | 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. | 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. | Posted | Number | Spearman correlation coefficient | Baseline, Days 28, 84, 168 |
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| Secondary | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 168 (or 12 weeks after the last dose of study drug) |
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From first dose of study drug up to Day 168
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HCV Genotype 1 Participants | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) | 0 | 41 | 0 | 41 | 9 | 41 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2018 | Sep 23, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| mITT Population |
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| mITT Population |
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| mITT Population |
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| 0.152 |
| mean change |
| -98373 |
| 2-Sided |
| 95 |
| -235667 |
| 38921 |
| Superiority |
| sdITT (n=26): Baseline vs. Day 168 | paired t-test | 0.091 | Superiority |
| mITT (n=24): Baseline vs. Day 168 | paired t-test | 0.152 | Superiority |
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