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®)
- Conditions
- Chronic Hepatitis C Virus (HCV)
- Registration Number
- NCT03002818
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- Treatment-naïve participants
- Mono-infected participants with chronic HCV GT1
- Non-cirrhotic participants
- Participants with debilitating fatigue (Fatigue Severity Scale [FSS] greater than or equal to 4)
- Participants with sources of fatigue other than HCV (especially, severe depression, cancer and hormonal disorders causing clinically significant fatigue)
- Participants with conditions that do not allow to adhere to protocol and use of the device at investigator's discretion
- Participants who are wheelchair dependent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline at Day 168 in Mean Daytime Physical Activity Baseline, Day 168 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.
- Secondary Outcome Measures
Name Time Method Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population Baseline, Days 28, 84, 168 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.
Change From Baseline Over Time in Mean Daytime Physical Activity Baseline, Days 28, 84, 168 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.
Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score Baseline, Days 28, 84, 168 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.
Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population Baseline, Days 28, 84, 168 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.
Change From Baseline Over Time in Sleep Efficiency Baseline, Days 28, 84, 168 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.
Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population Baseline, Days 28, 84, 168 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.
Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population Baseline, Days 28, 84, 168 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.
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment Day 168 (or 12 weeks after the last dose of study drug) 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).
Trial Locations
- Locations (5)
Inselspital, Universitaetsklin
🇨🇭Bern, Switzerland
Hopital Neuchatelois
🇨🇭Neuchatel, Switzerland
Universitaetsspital Zuerich
🇨🇭Zurich, Switzerland
Kantonsspital St. Gallen
🇨🇭St. Gallen, Sankt Gallen, Switzerland
Fondazione Epatocentro Ticino
🇨🇭Lugano, Switzerland