- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02726022
A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels
July 5, 2016 updated by: Hoffmann-La Roche
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
114
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aigaleo - Attiki, Greece, 12241
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Athens, Greece, 115 27
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Athens, Greece, 11527
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Athens, Greece, 11528
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Athens, Greece, 11522
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Athens, Greece, 11526
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Heraklion, Greece, 71100
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Piraeus, Greece, 18536
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Piraeus, Greece, 18454
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Thessaloniki, Greece, 546 42
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants with CHC and persistently normal ALT levels who have been receiving peginterferon alfa-2a and ribavirin for at least 4 weeks.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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As per treating physician discretion and according to summary of product characteristics.
Other Names:
As per treating physician discretion and according to summary of product characteristics.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline, EOT (up to 48 weeks)
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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).
|
Baseline, 24 weeks after EOT (up to 72 weeks)
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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).
|
Baseline, EOT (up to 48 weeks)
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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).
|
Baseline, 24 weeks after EOT (up to 72 weeks)
|
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).
|
Baseline, EOT (up to 48 weeks)
|
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).
|
Baseline, 24 weeks after EOT (up to 72 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
March 29, 2016
First Submitted That Met QC Criteria
March 29, 2016
First Posted (Estimate)
April 1, 2016
Study Record Updates
Last Update Posted (Estimate)
August 15, 2016
Last Update Submitted That Met QC Criteria
July 5, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
- Peginterferon alfa-2a
Other Study ID Numbers
- ML20151
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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