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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: | August 2006 |
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: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00087568 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Ribavirin Hepatitis, Viral, Human Angiogenesis Inhibitors Antiviral Agents |
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 Liver Diseases Flaviviridae Infections Hepatitis, Chronic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Ribavirin Physiological Effects of Drugs Hepatitis, Viral, Human Therapeutic Uses Hepatitis C Angiogenesis Modulating Agents |
Growth Inhibitors RNA Virus Infections Growth Substances Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Peginterferon alfa-2a Interferon Alfa-2a Hepatitis C, Chronic |