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Completed

NCT Number: 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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aigaleo - Attiki, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peginterferon alfa-2a

Drug

As per treating physician discretion and according to summary of product characteristics.

Other names: Pegasys

Ribavirin

Drug

As per treating physician discretion and according to summary of product characteristics.

Other names: Copegus

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 1, 2016
Registry last updated
Aug 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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