N/A
N=130
Quality of Life During Treatment of Chronic Hepatitis C (P05278/MK-4031-336)
Hepatitis C, Chronic · Genotype 1 · HCV-1
Bottom Line
View on ClinicalTrials.gov: NCT00863109 ↗Enrolled (actual)
130
Serious AEs
9.2%
Results posted
Jun 2014
Primary outcome: Primary: Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores — 87.27; 87.33; -1.56; 81.71 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Peginterferon alfa-2b (PEG) (Biological); Ribavirin (RBV) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores |
87.27; 87.33; -1.56; 81.71; 86.67; -0.56 | — |
| PRIMARY Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV) |
5.58; 5.76; -0.06; 5.19; 5.35; 0.10 | 0.027 sig |
| SECONDARY Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) |
-1.08; -3.75; -1.35; 3.13; -3.55; 4.13 | 0.038 sig |
| SECONDARY Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis) |
0.04; -0.50; 0.25; -0.57; 0.61; -0.58 | 0.014 sig |
| SECONDARY Minimal Clinically Important Difference (MCID) in SF-36 Scores |
4.29; 3.57; -0.67; 6.86; 4.29; -5.36 | — |
| SECONDARY MCID in CLDQ-HCV Scores |
0.00; 0.40; 1.00; 0.00; 0.40 | — |
| SECONDARY Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis) |
98.1; 0; 81.1; 0; 81.1; 0 | — |
Summary
The primary objective of this study is to evaluate the impact of chronic hepatitis C (CHC), and the treatment thereof with peginterferon alpha-2b (PEG) and ribavirin (RBV) according to standard clinical practice, on the health-related quality of life (HRQL) of a cohort of participants throughout 72 weeks of follow-up. HRQL was assessed using the 36-Item Short-Form Health Survey (SF-36) and the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV).
Eligibility Criteria
Inclusion Criteria
- Participants diagnosed with chronic hepatitis C (CHC)
- Participants with HCV genotype 1
- Participants who, at the time of the study, are referred to the Hospital Pharmacy Service to begin treatment with PEG and RBV for 48 weeks
- Available to understand and to give Informed Consent
Exclusion Criteria
- Participants co-infected with Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
Data sourced from ClinicalTrials.gov (NCT00863109). 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.