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®)

Chronic Hepatitis C Virus (HCV) Clinical Trial

— HEMATITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002818
• Other study ID #: P16-272
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: April 25, 2018

Study information

• Verified date: May 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 25, 2018
• Est. primary completion date: April 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus (HCV)
• Fatigue
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Switzerland	Inselspital, Universitaetsklin	Bern
Switzerland	Fondazione Epatocentro Ticino	Lugano
Switzerland	Hopital Neuchatelois	Neuchatel
Switzerland	Kantonsspital St. Gallen	St. Gallen	Sankt Gallen
Switzerland	Universitaetsspital Zuerich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, Day 168
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.	Baseline, Days 28, 84, 168
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.	Baseline, Days 28, 84, 168
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.	Baseline, Days 28, 84, 168
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.	Baseline, Days 28, 84, 168
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.	Baseline, Days 28, 84, 168
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.	Baseline, Days 28, 84, 168
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.	Baseline, Days 28, 84, 168
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).	Day 168 (or 12 weeks after the last dose of study drug)

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