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®)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-04-25

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Hepatitis C Virus (HCV)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HCV Genotype 1 Participants

Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No