Phase 4
Completed N=59
A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01033448 ↗
Enrolled (actual)
59
Serious AEs
8.5%
Results posted
Oct 2017
Primary outcomePrimary: End of Treatment Response Rate at Week 72 in Genotype 1 — 68.2 Percentage of Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY End of Treatment Response Rate at Week 72 in Genotype 1 |
68.2 | — |
| PRIMARY End of Treatment Response in Genotype 2 and 3 |
66.7 | — |
| PRIMARY Sustained Viral Response (SVR) Rates in CHC Genotype 1 |
46.5 | — |
| PRIMARY SVR Rates in Genotype 2 and 3. |
60.0 | — |
| SECONDARY Percentage of Participants With Adverse Event (AE) |
40.7 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients >/= 18 years of age
- Chronic hepatitis C, genotype 1, 2, 3
- Compensated liver disease
- Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders
Exclusion Criteria
- Decompensated liver disease
- Signs or symptoms of hepatocellular carcinoma
- Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT01033448). 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.