N/A
N=443
An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin
Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01392742 ↗Enrolled (actual)
443
Serious AEs
3.9%
Results posted
Dec 2015
Primary outcome: Primary: Percentage of Participants With Sustained Virological Response (SVR) — 38.7 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virological Response (SVR) |
38.7 | — |
| PRIMARY Percentage of Participants With Relapse |
8.2 | — |
| PRIMARY Percentage of Participants Who Were Non-Responders |
25.1 | — |
| SECONDARY Percentage of Participants With Positive Predictive Value on SVR at Week 4 |
64.8; 20.0 | — |
| SECONDARY Percentage of Participants With Positive Predictive Value on SVR at Week 12 |
69.8; 25.0 | — |
| SECONDARY Correlation of SVR With Rapid Virological Response (RVR) |
0.378; 0.310; 0.782 | — |
| SECONDARY Correlation of SVR With Early Virological Response (EVR) |
0.570; 0.470; 1.000 | — |
| SECONDARY Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response |
2.540; 1.390; 7.030; 2.320; -0.091; 0.020 | 0.000 sig |
| SECONDARY Duration of Treatment in Participants With SVR by HCV Genotype |
329.95; 173.25; 335.00 | — |
| SECONDARY Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype |
24701.70; 13030.71; 25842.86 | — |
| SECONDARY Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype |
1062607; 538812.50; 1005000 | — |
| SECONDARY Percentage of Participants With Virological Response |
46.8 | — |
Summary
This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of treatment.
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Serologically confirmed chronic hepatitis C (all genotypes)
- Treatment with Pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (SPCs)/local labelling
Exclusion Criteria
- Coinfection with HIV and/or hepatitis B
- Contraindications according to the SPC for Pegasys/ribavirin
Data sourced from ClinicalTrials.gov (NCT01392742). 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.