Clinical trial NCT03002818: 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®)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C Virus (HCV)
Keywords: Chronic Hepatitis C (HCV)
Genotype 1
Paritaprevir
Ritonavir
ombitasvir
Dasabuvir
Sustained Virological Response
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-12-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with CHC, genotype 1, receiving paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (3D regimen)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline at Day 168 in Mean Daytime Physical Activity
timeFrame: Baseline, Day 168
Secondary outcomes:
measure: Change From Baseline Over Time in Mean Daytime Physical Activity
timeFrame: Baseline, Days 28, 84, 168
measure: Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score
timeFrame: Baseline, Days 28, 84, 168
measure: Change From Baseline Over Time in Sleep Efficiency
timeFrame: Baseline, Days 28, 84, 168
measure: Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population
timeFrame: Baseline, Days 28, 84, 168
measure: Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population
timeFrame: Baseline, Days 28, 84, 168
measure: Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population
timeFrame: Baseline, Days 28, 84, 168
measure: Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population
timeFrame: Baseline, Days 28, 84, 168
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)
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
state: Sankt Gallen
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsklin
city: Lugano
country: Switzerland
facility: Fondazione Epatocentro Ticino
city: Neuchatel
country: Switzerland
facility: Hopital Neuchatelois
city: Zurich
country: Switzerland
facility: Universitaetsspital Zuerich
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
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.