Chronic Hepatitis C Virus (HCV)HEMATITENCT03002818

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®)

An observational study of Chronic Hepatitis C Virus (HCV), run by AbbVie at 5 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Chronic Hepatitis C Virus (HCV)
How many people: 41 participants
Where: 5 sitesSwitzerland
Study dates: 1 Mar 2017to 25 Apr 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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)

Who cannot join

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 locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Switzerland5 sites

Inselspital, Universitaetsklin
Bern, 3010
Fondazione Epatocentro Ticino
Lugano, 6900
Hopital Neuchatelois
Neuchâtel, CH-2000
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Universitaetsspital Zuerich
Zurich, 8091

Other trials in Switzerland

About this study

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

Conditions: Chronic Hepatitis C Virus (HCV)
Keywords: Chronic Hepatitis C (HCV), Genotype 1, Paritaprevir, Ritonavir, ombitasvir, Dasabuvir, Sustained Virological Response
Medical subject headings: Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03002818
Study group	Role	What they receive
HCV Genotype 1 Participants		Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Day 168

Secondary outcomes (8)

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.
Measured: Baseline, Days 28, 84, 168
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.
Measured: Baseline, Days 28, 84, 168
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.
Measured: Baseline, Days 28, 84, 168
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.
Measured: Baseline, Days 28, 84, 168
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.
Measured: Baseline, Days 28, 84, 168
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.
Measured: Baseline, Days 28, 84, 168
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.
Measured: Baseline, Days 28, 84, 168
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).
Measured: Day 168 (or 12 weeks after the last dose of study drug)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201725 Apr 2018

First posted26 Dec 2016 (estimated)
Study start1 Mar 2017
Primary completion25 Apr 2018
Study completion25 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis C Virus (HCV)Studies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03002818
Sponsor's protocol ID: P16-272
Acronym: HEMATITE
Status last verified: May 2018
First submitted: 15 Dec 2016
Last updated: 23 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 33147283

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C Virus (HCV) trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03002818
Acronym / sponsor ID: HEMATITE / P16-272
Conditions: Chronic Hepatitis C Virus (HCV)
Keywords: Chronic Hepatitis C (HCV), Genotype 1, Paritaprevir, Ritonavir, ombitasvir, Dasabuvir, Sustained Virological Response
Study type: Observational
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 1 Mar 2017 (actual)
Primary completion: 25 Apr 2018 (actual)
Study completion: 25 Apr 2018 (actual)
First posted: 26 Dec 2016 (estimated)
Results: Posted 23 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
HCV Genotype 1 Participants	–	–Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen)

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with CHC, genotype 1, receiving paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (3D regimen)

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change From Baseline at Day 168 in Mean Daytime Physical Activity
Time frame: Baseline, Day 168
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.

8 secondary outcomes

Change From Baseline Over Time in Mean Daytime Physical Activity
Time frame: Baseline, Days 28, 84, 168
Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score
Time frame: Baseline, Days 28, 84, 168
Change From Baseline Over Time in Sleep Efficiency
Time frame: Baseline, Days 28, 84, 168
Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population
Time frame: Baseline, Days 28, 84, 168
Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population
Time frame: Baseline, Days 28, 84, 168
Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population
Time frame: Baseline, Days 28, 84, 168
Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population
Time frame: Baseline, Days 28, 84, 168
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment
Time frame: Day 168 (or 12 weeks after the last dose of study drug)

Results and safety

Results posted to the registry on 23 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hepatitis C Virus (HCV) Genotype 1 Participants	41	40

Primary outcome: Change From Baseline at Day 168 in Mean Daytime Physical Activity

Time frame: Baseline, Day 168. Mean (Standard Deviation). Unit: day-counts

Measure	HCV Genotype 1 Participants n = 26
Change at Day 168: sdITT Population	-108266 (313859)
Change at Day 168: mITT Population	-98373 (325138)

HCV Genotype 1 Participants: mean change: -108266 (95% CI -235037 to 18504), p = 0.091, one-sample t-test
HCV Genotype 1 Participants: mean change: -98373 (95% CI -235667 to 38921), p = 0.152, one-sample t-test
HCV Genotype 1 Participants: p = 0.091, paired t-test

Population analysed: ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug up to Day 168. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HCV Genotype 1 Participants	0 of 41 (0%)	9 of 41 (22%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33147283Semmo 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Chronic Hepatitis C Virus (HCV)

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AbbVie Inc. study director

AbbVie

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis C Virus (HCV), run by AbbVie at 5 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline at Day 168 in Mean Daytime Physical Activity (time frame: Baseline, Day 168). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03002818, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.