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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-04-01
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)
timeFrame: Baseline, EOT (up to 48 weeks)
measure: Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
timeFrame: Baseline, 24 weeks after EOT (up to 72 weeks)
measure: Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT
timeFrame: Baseline, EOT (up to 48 weeks)
measure: Change From Baseline in SF-36 PCS at 24 Weeks After EOT
timeFrame: Baseline, 24 weeks after EOT (up to 72 weeks)
measure: Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT
timeFrame: Baseline, EOT (up to 48 weeks)
measure: Change From Baseline in SF-36 MCS at 24 Weeks After EOT
timeFrame: Baseline, 24 weeks after EOT (up to 72 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Aigaleo - Attiki
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Heraklion
country: Greece
city: Piraeus
country: Greece
city: Piraeus
country: Greece
city: Thessaloniki
country: Greece
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: