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A Study of Combination Treatment With PEGASYS (Peginterferon Alfa-2a (40KD) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C.

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: peginterferon alfa-2a [Pegasys] (Drug); peginterferon alfa-2a [Pegasys] (Drug); ribavirin [Copegus] (Drug); ribavirin [Copegus] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This 3 arm study will assess the safety and efficacy of combination treatment with PEGASYS + Copegus in patients with chronic hepatitis C. Three groups of patients will be studied; 1) those with elevated ALT level, 2) those with normal ALT level, and 3) those with HIV co-infection. Patients with genotype 1, 4, 5 or 6 will receive PEGASYS 180 micrograms sc once weekly + Copegus 1000-1200mg po daily (dependent on body weight) for 48 weeks, those with genotype 2 or 3 will receive PEGASYS 180 micrograms sc once weekly + Copegus 800mg po daily for 24 weeks, and all patients with HIV co-infection will receive PEGASYS 180 micrograms sc once weekly + Copegus 800mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Clinical Details

Official title: An Open Label Study Assessing the Safety and Effect on Viral Response of Combination Therapy With PEGASYS + COPEGUS in Selected Groups of Patients With Chronic Viral Hepatitis C

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Occurrence rate and intensity of adverse events

Secondary outcome:

Sustained viral response

Viral response rate

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients >= 18 years of age;

- chronic hepatitis C, with detectable serum HCV RNA;

- scheduled for treatment with PEGASYS;

- compensated liver disease.

Exclusion Criteria:

- chronic liver disease other than chronic hepatitis C;

- active HAV or HBV infection;

- therapy with any systemic antiviral, antineoplastic or immunomodulatory treatment <=

6 months prior to first dose of study drug.

Locations and Contacts

Beroun, Czech Republic

Brno 62500, Czech Republic

Ceska Lipa, Czech Republic

Ceské Budejovice 370 87, Czech Republic

Chomutov, Czech Republic

Decin, Czech Republic

Havirov, Czech Republic

Havlickuv Brod, Czech Republic

Hradec Kralove 500 12, Czech Republic

Hradec Kralove, Czech Republic

Jablonec/nisou 466 60, Czech Republic

Jihlava, Czech Republic

Karlovy Vary, Czech Republic

Kolin, Czech Republic

Liberec, Czech Republic

Melnik, Czech Republic

Most, Czech Republic

Olomouc, Czech Republic

Opava, Czech Republic

Ostrava 708 52, Czech Republic

Pardubice, Czech Republic

Praha 2 128 08, Czech Republic

Praha 00000, Czech Republic

Praha 140 00, Czech Republic

Praha 180 01, Czech Republic

Praha, Czech Republic

Prostejov, Czech Republic

Usti Nad Labem, Czech Republic

Banska Bystrica 957 17, Slovakia

Bratislava 833 05, Slovakia

Bratislava 851 07, Slovakia

Kosice 040 01, Slovakia

Kosice 04001, Slovakia

Martin 036 59, Slovakia

Trencin 911 07, Slovakia

Additional Information

Starting date: January 2006
Last updated: May 5, 2014

Page last updated: August 23, 2015

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