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®) (HEMATITE)
Status
Completed
Conditions
Chronic Hepatitis C Virus (HCV)
Details and patient eligibility
About
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.
Enrollment
41 patients
Sex
All
Ages
18 to 99 years old
Volunteers
No Healthy Volunteers
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
Trial design
41 participants in 1 patient group
HCV Genotype 1 Participants
Description:
Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)
Trial contacts and locations
5
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Data sourced from clinicaltrials.gov
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