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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00087568 |
This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is >100 individuals.
Condition | Intervention | Phase |
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Hepatitis C, Chronic |
Drug: peginterferon alfa-2a [PEGASYS] Drug: Ribavirin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | An Open-Label Study of the Safety and Tolerability of PEGASYS Plus Ribavirin in Patients With Chronic Hepatitis C Viral Infection Who Could Not Tolerate or Were Unresponsive to PEG-Intron Plus Ribavirin |
Enrollment: | 58 |
Study Completion Date: | January 2005 |
Arms | Assigned Interventions |
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1: Experimental
1
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Drug: peginterferon alfa-2a [PEGASYS]
180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)
Drug: Ribavirin
1000/1200mg po bid for 36 or 60 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:
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML16965 |
Study First Received: | July 12, 2004 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00087568 |
Health Authority: | United States: Food and Drug Administration |
Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Ribavirin Hepatitis, Viral, Human Hepatitis Virus Diseases |
Digestive System Diseases Peginterferon alfa-2b Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic Interferon Alfa-2b |
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 |