A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: peginterferon alfa-2a (40KD) [PEGASYS] (Drug); Copegus (Drug); Copegus (Drug); peginterferon alfa-2a (40KD) [PEGASYS] (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

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 genotype 1 infection of high viral titer, and baseline body weight >=85kg, will be randomized to one of 4 groups, to receive a)PEGASYS 180 micrograms sc weekly plus Copegus 1200mg po daily, b)PEGASYS 180 micrograms sc weekly plus Copegus 1400-1600mg po daily, c)PEGASYS 360 micrograms sc weekly (induction) followed by 180 micrograms sc weekly (maintenance) plus Copegus 1200mg po daily or d)PEGASYS 360 micrograms sc weekly (induction) followed by 180 micrograms sc weekly (maintenance) plus Copegus 1400-1600mg 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.

Official title: A Randomized, Double-Blind Study of the Effect on Sustained Viral Response, and the Safety, of Standard or 360 ug PEGASYS Induction Dosing in Combination With Standard or Higher Dose Copegus in Treatment-Naive Chronic Hepatitis C Patients Weighing >85kg With Genotype 1 High Viral Titer Infection

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: SVR

Secondary outcome:

SVR

Virological response

AEs, laboratory parameters, Beck Depression Inventory

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

Criteria:

Inclusion Criteria:

- adult patients, >=18 years of age;

- CHC infection, genotype 1;

- HCV RNA >=400,000 IU/mL;

- baseline body weight >=85kg;

- 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.

BRUXELLES 1200, Belgium

GENT 9000, Belgium

BRUXELLES 1030, Belgium

BRUXELLES 1070, Belgium

BRUXELLES 1000, Belgium

CAIXA 18618-970, Brazil

SAO PAULO 01307, Brazil

CAMPINAS 13083-888, Brazil

SALVADOR 40110-170, Brazil

PORTO ALEGRE 90035-003, Brazil

PORTO ALEGRE 91350-200, Brazil

JUIZ DE FORA 36036-330, Brazil

SAO JOSE DO RIO PRETO 15090-000, Brazil

ODENSE 5000, Denmark

LILLE 59037, France

CLERMONT-FERRAND 63000, France

CLICHY 92118, France

BERLIN 13353, Germany

HAMBURG 20246, Germany

KIEL 24105, Germany

FRANKFURT AM MAIN 60590, Germany

FREIBURG 79106, Germany

KÖLN 50937, Germany

BONN 531105, Germany

DÜSSELDORF 40225, Germany

GIESSEN 35392, Germany

TÜBINGEN 72076, Germany

HEIDELBERG 69120, Germany

PECS 7654, Hungary

GYULA 5700, Hungary

DEBRECEN 4012, Hungary

BUDAPEST 1097, Hungary

BUDAPEST 1083, Hungary

BEKESCSABA 5600, Hungary

GYOR 9024, Hungary

ROTTERDAM 3015 GD, Netherlands

WROCLAW 51-124, Poland

LODZ 91-347, Poland

BYDGOSZCZ 85-030, Poland

KIELCE 25-317, Poland

CHORZOW 41-500, Poland

WARSZAWA 01-201, Poland

SANTURCE 00909, Puerto Rico

SAN JUAN 00936-5067, Puerto Rico

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BUCHAREST 022328, Romania

CLUJ-NAPOCA, Romania

BUCHAREST 010825, Romania

CONSTANTA, Romania

BUCHAREST 021105, Romania

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TIMISOARA, Romania

IASI 700111, Romania

MOSCOW 105229, Russian Federation

MOSCOW 143420, Russian Federation

SMOLENSK 214006, Russian Federation

ST PETERSBURG 194044, Russian Federation

JALOSLAVE --, Russian Federation

MOSCOW 119881, Russian Federation

STAVROPOL 355017, Russian Federation

MOSCOW 11/5, Russian Federation

MOSCOW 115446, Russian Federation

NIZHNY NOVGOROD 603022, Russian Federation

MOSCOW 103287, Russian Federation

MOSCOW 117333, Russian Federation

SAMARA 443011, Russian Federation

STOCKHOLM, Sweden

UPPSALA 75185, Sweden

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Starting date: February 2007
Ending date: March 2009
Last updated: June 17, 2008