NCT03002818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 23, 2019

Completed
Last Updated

October 23, 2019

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

December 15, 2016

Results QC Date

September 30, 2019

Last Update Submit

September 30, 2019

Conditions

Chronic Hepatitis C Virus (HCV)

Keywords

Chronic Hepatitis C (HCV)Genotype 1ParitaprevirRitonavirombitasvirDasabuvirSustained Virological Response

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change From Baseline Over Time in Mean Daytime Physical Activity

    Baseline, Days 28, 84, 168

  • Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score

    Baseline, Days 28, 84, 168

  • Change From Baseline Over Time in Sleep Efficiency

    Baseline, Days 28, 84, 168

  • Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population

    Baseline, Days 28, 84, 168

  • Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population

    Baseline, Days 28, 84, 168

  • +3 more secondary outcomes

Study Arms (1)

HCV Genotype 1 Participants

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with CHC, genotype 1, receiving paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (3D regimen)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Inselspital, Universitaetsklin

Bern, 3010, Switzerland

Location

Fondazione Epatocentro Ticino

Lugano, 6900, Switzerland

Location

Hopital Neuchatelois

Neuchâtel, CH-2000, Switzerland

Location

Universitaetsspital Zuerich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 33147283DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
abbvieclinicaltrials@abbvie.com
800-633-9110

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 26, 2016

Study Start

March 1, 2017

Primary Completion

April 25, 2018

Study Completion

April 25, 2018

Last Updated

October 23, 2019

Results First Posted

October 23, 2019

Record last verified: 2018-05

Locations

CH(5)