Phase 4
Completed N=1,175
A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00394277 ↗
Enrolled (actual)
1,175
Serious AEs
10.2%
Results posted
Jul 2010
Primary outcomePrimary: Sustained Virological Response (SVR)-24 (Scheduled Treatment Period) — 37.7; 42.9; 43.5; 40.7 Percentage of patients — p=0.584
Summary
This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virological Response (SVR)-24 (Scheduled Treatment Period) |
37.7; 42.9; 43.5; 40.7 | 0.584 |
| SECONDARY SVR-24 (Actual Treatment Period) |
38.2; 43.9; 43.5; 40.7 | 0.775 |
| SECONDARY SVR-12 (Scheduled Treatment Period) |
40.3; 45.0; 44.2; 41.5 | 0.973 |
| SECONDARY SVR-12 (Actual Treatment Period) |
40.3; 45.5; 44.2; 42.3 | 0.951 |
Eligibility Criteria
Inclusion Criteria
- Adult patients, ≥18 years of age
- CHC infection, genotype 1
- Hepatitis C virus (HCV) RNA ≥400, 000 IU/mL
- Baseline body weight ≥85 kg
- Liver biopsy (within 24 months of first dose) with results consistent with CHC
Exclusion Criteria
- Previous treatment with interferon, ribavirin, viramidine, levovirin, HCV polymerase or protease inhibitors
- Other forms of liver disease, including liver cancer
- Human immunodeficiency virus infection
Data sourced from ClinicalTrials.gov (NCT00394277). 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.