Phase 3
Completed N=188
A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00623428 ↗
Enrolled (actual)
188
Serious AEs
8.0%
Results posted
Jun 2013
Primary outcomePrimary: Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment — 52; 57 percentage of participants — p=0.4557
Summary
This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment |
52; 57 | 0.4557 |
| PRIMARY Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment |
52; 61 | 0.1934 |
| SECONDARY Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation |
44; 57 | 0.0788 |
| SECONDARY Percentage of Participants With Virological Response at End of Treatment |
93; 90 | 0.5654 |
| SECONDARY Percentage of Participants With Virological Relapse |
41; 29 | — |
| SECONDARY Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment |
52; 61 | 0.1934 |
| SECONDARY Number of Participants With Adverse Events (AEs) |
81; 88; 13; 24; 78; 86 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- serological evidence of chronic hepatitis C (CHC);
- CHC genotype 2 or 3;
- receiving PEGASYS + Copegus according to local standard of care and no rapid viral response (RVR);
- compensated liver disease.
Exclusion Criteria
- pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
- coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);
- history or other evidence of decompensated liver disease.
Data sourced from ClinicalTrials.gov (NCT00623428). 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. Informational only — not medical advice.