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).

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

262 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Peginterferon Alfa-2a + Ribavirin

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 micrograms/week sc for 24 weeks

ribavirin [Copegus]

Intervention Type DRUG

800mg po daily for 24 weeks

Interventions

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peginterferon alfa-2a [Pegasys]

180 micrograms/week sc for 24 weeks

Intervention Type DRUG

ribavirin [Copegus]

800mg po daily for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No