Hepatitis C, ChronicNCT02726022

A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 10 sites in Greece.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Peginterferon alfa-2a and Ribavirin
How many people: 114 participants
Where: 10 sitesGreece
Study dates: Feb 2007to Jul 2011
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants with CHC and persistently normal ALT levels who have been receiving peginterferon alfa-2a and ribavirin for at least 4 weeks.

Who may be able to join

Serological confirmation of chronic infection by anti-hepatitis C virus (HCV) assay
HCV ribonucleic acid (RNA) positive
CHC with normal transaminases
Compensated liver disease
Non-pregnant and willing to use two contraceptive methods (if fertile)
At least 4 weeks of prior treatment with peginterferon alfa-2a and ribavirin

Who cannot join

Pregnant or lactating women
Co-infection with hepatitis A or B, or human immunodeficiency virus (HIV)
History of seizures or depression
History of autoimmune disease, severe heart or lung disease, or renal failure with reduced creatinine clearance
Uncontrolled thyroid disease
Severe retinopathy
Leukopenia or thrombocytopenia
Bleeding esophageal varices or other evidence of hepatic decompensation

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Greece10 sites

Study site
Aigaleo - Attiki, 12241
Study site
Athens, 115 27
Study site
Athens, 11522
Study site
Athens, 11526
Study site
Athens, 11527
Study site
Athens, 11528
Study site
Heraklion, 71100
Study site
Piraeus, 18454
Study site
Piraeus, 18536
Study site
Thessaloniki, 546 42

Other trials in Greece

About this study

Official title: A Quality of Life Study of PEGASYS® (Peginterferon-Alfa2a) in Combination With COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C and Persistently Normal ALT Levels

Participants with Chronic Hepatitis C (CHC) and normal ALT, who have been under treatment with peginterferon alfa-2a and ribavirin for at least 4 weeks, will be enrolled into this non-interventional, open-label study. The primary aim is to evaluate quality of life according to the 36-Item Short-Form Health Survey (SF-36) questionnaire, modified for the Greek population.

Conditions: Hepatitis C, Chronic
Being tested: Peginterferon alfa-2a, Ribavirin
Medical subject headings: Hepatitis C, Chronic

What participants receive

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

Peginterferon alfa-2aDrug
Also called Pegasys
As per treating physician discretion and according to summary of product characteristics.
RibavirinDrug
Also called Copegus
As per treating physician discretion and according to summary of product characteristics.

Study groups in NCT02726022
Study group	Role	What they receive
Chronic Hepatitis C Participants		Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, will be observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin will be administered as per treating physician discretion and according to summary of product characteristics. Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin

What is being measured

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

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Measured: Baseline, EOT (up to 48 weeks)
Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Measured: Baseline, 24 weeks after EOT (up to 72 weeks)
Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Measured: Baseline, EOT (up to 48 weeks)
Change From Baseline in SF-36 PCS at 24 Weeks After EOT
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Measured: Baseline, 24 weeks after EOT (up to 72 weeks)
Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Measured: Baseline, EOT (up to 48 weeks)
Change From Baseline in SF-36 MCS at 24 Weeks After EOT
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Measured: Baseline, 24 weeks after EOT (up to 72 weeks)

Timeline

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

Feb 2007Jul 2011

First posted1 Apr 2016 (estimated)
Study startFeb 2007
Primary completionJul 2011
Study completionJul 2011

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.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe 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: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02726022
Sponsor's protocol ID: ML20151
Status last verified: Apr 2016
First submitted: 29 Mar 2016
Last updated: 15 Aug 2016
Results posted: Yes, on ClinicalTrials.gov

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 Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Quality of Life Study of PEGASYS® (Peginterferon-Alfa2a) in Combination With COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C and Persistently Normal ALT Levels
ClinicalTrials.gov ID: NCT02726022
Acronym / sponsor ID: ML20151
Conditions: Hepatitis C, Chronic
Study type: Observational
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 1 Apr 2016 (estimated)
Results: Posted 15 Aug 2016

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
Chronic Hepatitis C Participants	–	Drug: Peginterferon alfa-2a, Drug: RibavirinParticipants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, will be observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin will be administered as per treating physician discretion and according to summary of product characteristics.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with CHC and persistently normal ALT levels who have been receiving peginterferon alfa-2a and ribavirin for at least 4 weeks.

Key inclusion criteria (6 listed)

Serological confirmation of chronic infection by anti-hepatitis C virus (HCV) assay
HCV ribonucleic acid (RNA) positive
CHC with normal transaminases
Compensated liver disease
Non-pregnant and willing to use two contraceptive methods (if fertile)

Key exclusion criteria (8 listed)

Pregnant or lactating women
Co-infection with hepatitis A or B, or human immunodeficiency virus (HIV)
History of seizures or depression
History of autoimmune disease, severe heart or lung disease, or renal failure with reduced creatinine clearance
Uncontrolled thyroid disease

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

Interventions

Intervention	Type	Arms
Peginterferon alfa-2aAlso: PegasysAs per treating physician discretion and according to summary of product characteristics.	Drug	Chronic Hepatitis C Participants
RibavirinAlso: CopegusAs per treating physician discretion and according to summary of product characteristics.	Drug	Chronic Hepatitis C Participants

Primary outcome

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)
Time frame: Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
Time frame: Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT
Time frame: Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Change From Baseline in SF-36 PCS at 24 Weeks After EOT
Time frame: Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT
Time frame: Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Change From Baseline in SF-36 MCS at 24 Weeks After EOT
Time frame: Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).

Results and safety

Results posted to the registry on 15 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chronic Hepatitis C Participants	114	78

Primary outcome: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)

Time frame: Baseline, EOT (up to 48 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Chronic Hepatitis C Participants n = 76
Gender: Male	-3.2 (24.6)
Gender: Female	-3.0 (29.2)
Drug Addiction: Yes	-7.4 (26.5)
Drug Addiction: No	-1.2 (27.1)

Chronic Hepatitis C Participants: p = 0.647, Fisher Exact
Chronic Hepatitis C Participants: p = 0.373, Fisher Exact

Population analysed: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.

Primary outcome: Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT

Time frame: Baseline, 24 weeks after EOT (up to 72 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Chronic Hepatitis C Participants n = 56
Gender: Male	0.3 (26.3)
Gender: Female	15.4 (25.0)
Drug Addiction: Yes	8.4 (18.7)
Drug Addiction: No	7.6 (29.1)

Chronic Hepatitis C Participants: p = 0.049, Fisher Exact
Chronic Hepatitis C Participants: p = 0.860, Fisher Exact

Population analysed: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.

Primary outcome: Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT

Time frame: Baseline, EOT (up to 48 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Chronic Hepatitis C Participants n = 76
Gender: Male	-0.7 (24.6)
Gender: Female	0.17 (26.5)
Drug Addiction: Yes	-0.4 (18.7)
Drug Addiction: No	-0.1 (27.7)

Chronic Hepatitis C Participants: p = 0.921, Fisher Exact
Chronic Hepatitis C Participants: p = 0.962, Fisher Exact

Primary outcome: Change From Baseline in SF-36 PCS at 24 Weeks After EOT

Time frame: Baseline, 24 weeks after EOT (up to 72 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Chronic Hepatitis C Participants n = 56
Gender: Male	0.1 (27.5)
Gender: Female	15.8 (23.8)
Drug Addiction: Yes	6.7 (17.1)
Drug Addiction: No	8.4 (29.6)

Chronic Hepatitis C Participants: p = 0.052, Fisher Exact
Chronic Hepatitis C Participants: p = 0.677, Fisher Exact

Population analysed: Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.

Adverse events

Time frame: Baseline up to Week 72. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Hepatitis C Participants	1 of 114 (0.9%)	27 of 114 (23.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C, Chronic

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.

Clinical Trials study director

Hoffmann-La Roche

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

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 10 sites in Greece.

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 6 inclusion and 8 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 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Greece. 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 15 Aug 2016). 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 in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT) (time frame: Baseline, EOT (up to 48 weeks)). The study lists 6 primary outcomes in all. 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 NCT02726022.

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 15 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.