N/A
Completed N=262
POTENTE Study: A Study of Early Virological Response in Naive Patients With Chronic Hepatitis C, Genotype 2 or 3, Treated With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin).
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00700401 ↗
Enrolled (actual)
262
Serious AEs
5.0%
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virological Response at Week 48 — 52.7 Percentage of participants
Summary
This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virological Response at Week 48 |
52.7 | — |
| SECONDARY Percentage of Participants With Rapid Virological Response at Week 4 |
56.9 | — |
| SECONDARY Percentage of Participants With Virological Response at Week 24 |
56.9 | — |
| SECONDARY Percentage of Participants With Virological Relapse |
9.4 | — |
| SECONDARY Percentage of Participants With Positive Predictive Value |
85.2 | — |
| SECONDARY Number of Participants With Any Adverse Events and Any Serious Adverse Events |
196; 13 | — |
| SECONDARY Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 |
-8.4; -15.7; -19.6; -20.7; -2.2; -8.1 | — |
| SECONDARY Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 |
-28.5; -30.4; -30; -61.8; -19.6; -10.2 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- positive serum HCV RNA.
Exclusion Criteria
- co-infection with HIV or HBV (patients with a positive HBsAg);
- previous treatment with interferon, or peginterferon and/or ribavirin;
- severe hepatic dysfunction or decompensated cirrhosis of liver.
Data sourced from ClinicalTrials.gov (NCT00700401). 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.