N/A
N=114
A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels
Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT02726022 ↗Enrolled (actual)
114
Serious AEs
0.9%
Results posted
Aug 2016
Primary outcome: Primary: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT) — -3.2; -3.0; -7.4; -1.2 units on a scale — p=0.647
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Peginterferon alfa-2a (Drug); Ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT) |
-3.2; -3.0; -7.4; -1.2 | 0.647 |
| PRIMARY Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT |
0.3; 15.4; 8.4; 7.6 | 0.049 sig |
| PRIMARY Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT |
-0.7; 0.17; -0.4; -0.1 | 0.921 |
| PRIMARY Change From Baseline in SF-36 PCS at 24 Weeks After EOT |
0.1; 15.8; 6.7; 8.4 | 0.052 |
| PRIMARY Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT |
-5.10; -3.47; -9.4; -2.1 | 0.720 |
| PRIMARY Change From Baseline in SF-36 MCS at 24 Weeks After EOT |
-3.2; 6.5; 4.4; 0.9 | 0.184 |
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
Data sourced from ClinicalTrials.gov (NCT02726022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.