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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00800748 |
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.
Condition | Intervention | Phase |
---|---|---|
Hepatitis C, Chronic |
Drug: peginterferon alfa-2a (40KD) [PEGASYS] Drug: ribavirin [Copegus] |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 400 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | May 2010 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks (genotype 1, 4, 5, 6), or 24 weeks (genotype 2, 3)
Drug: ribavirin [Copegus]
1000-1200mg po daily for 48 weeks (genotype 1, 4, 5, 6) or 800mg po daily for 24 weeks (genotype 2,3)
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2: Experimental |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks (genotype 1, 4, 5, 6), or 24 weeks (genotype 2, 3)
Drug: ribavirin [Copegus]
1000-1200mg po daily for 48 weeks (genotype 1, 4, 5, 6) or 800mg po daily for 24 weeks (genotype 2,3)
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3: Experimental |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks
Drug: ribavirin [Copegus]
800mg po daily for 48 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Czech Republic | |
BRNO, Czech Republic, 62500 | |
PRAHA, Czech Republic | |
PRAHA, Czech Republic, 00000 | |
OLOMOUC, Czech Republic | |
KARLOVY VARY, Czech Republic, 360 73 | |
JABLONEC/NISOU, Czech Republic, 466 60 | |
PRAHA, Czech Republic, 180 01 | |
PRAHA 2, Czech Republic, 128 08 | |
MELNIK, Czech Republic | |
HRADEC KRALOVE, Czech Republic, 500 12 | |
OSTRAVA, Czech Republic, 708 52 | |
OPAVA, Czech Republic | |
CESKÉ BUDEJOVICE, Czech Republic, 370 87 | |
USTI NAD LABEM, Czech Republic | |
BEROUN, Czech Republic | |
HAVLICKUV BROD, Czech Republic | |
HRADEC KRALOVE, Czech Republic | |
LIBEREC, Czech Republic, 460 63 | |
HAVIROV, Czech Republic | |
PARDUBICE, Czech Republic, 532 03 | |
PROSTEJOV, Czech Republic | |
MOST, Czech Republic | |
DECIN, Czech Republic | |
KOLIN, Czech Republic | |
CESKA LIPA, Czech Republic | |
CHOMUTOV, Czech Republic, 43012 | |
JIHLAVA, Czech Republic, 586 33 | |
Slovakia | |
BRATISLAVA, Slovakia, 833 05 | |
BRATISLAVA, Slovakia, 851 07 | |
TRENCIN, Slovakia, 911 07 | |
KOSICE, Slovakia, 04001 | |
MARTIN, Slovakia, 036 59 | |
KOSICE, Slovakia, 040 01 | |
BANSKA BYSTRICA, Slovakia, 957 17 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML19387 |
Study First Received: | December 1, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00800748 |
Health Authority: | Czech Republic: State Institute for Drug Control |
Interferon-alpha Liver Diseases Hepatitis, Chronic Ribavirin Interferons Hepatitis, Viral, Human Hepatitis |
Virus Diseases Digestive System Diseases Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents RNA Virus Infections Flaviviridae Infections Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |