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Sponsored by: |
Kaohsiung Medical University Chung-Ho Memorial Hospital |
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Information provided by: | Kaohsiung Medical University Chung-Ho Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00540345 |
The purposes of this study are:
Condition | Intervention | Phase |
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Chronic Hepatitis C Genotype |
Drug: pegylated interferon alpha 2a and plus ribavirin Drug: Pegylated interferon alfa-2a and ribavirin Drug: pegylated interferon alpha 2a and ribavirin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Four Arms, Multicenter, Open Label Study of Tailored Regimens With Peginterferon Plus Ribavirin for Genotype 2 Chronic Hepatitis C |
Estimated Enrollment: | 310 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Patients who have a RVR will be randomized into two groups with a ratio of 1:1 (Arm A & B)
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Drug: Pegylated interferon alfa-2a and ribavirin
pegylated interferon alfa-2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 16 weeks, follow up for 24 weeks
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B: Active Comparator
Patients who have a RVR will be randomized into two groups with a ratio of 1:1 (Arm A & B)
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Drug: pegylated interferon alpha 2a and plus ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 4 weeks followed by pegylated interferon alpha 2a 180 mcg/week and Ribavirin 800 mg/day for 12 weeks, follow up for 24 weeks
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C: Active Comparator
For patients who do not have a RVR will be randomized into two groups with a ratio of 1:1 (Arm C & D)
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Drug: pegylated interferon alpha 2a and ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
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D: Active Comparator
For patients who do not have a RVR will be randomized into two groups with a ratio of 1:1 (Arm C & D)
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Drug: pegylated interferon alpha 2a and ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 48 weeks, follow up for 24 weeks
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The recommended regimen for treating HCV genotype 2 patients is peginterferon plus low dose ribavirin (800 mg/day) for 24 weeks. Recently studies have demonstrated that a shorter treatment duration of 12-16 weeks of peginterferon plus standard weight-based dose of ribavirin (800-1400 mg/day) is as effective as a 24-week regimen among HCV genotype 2 patients with a RVR at week 4 of treatment (rate of sustained virological response, SVR, approximately 90%). However, for patients without a RVR at week 4 the efficacy of 24 week treatment remains unsatisfied. Individualized therapy with tailored regimen according to baseline and on-treatment virological factors, without compromising efficacy, is the future strategy in the management of chronic hepatitis C.
The aims of the present study are
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ming-Lung Yu, MD, PhD | 886 7 3208282 | fishya@ms14.hinet.net; fish6069@gmail.com |
Taiwan | |
Kaohsiung Medical University Hospital | Recruiting |
Kaohsiung, Taiwan, 807 | |
Contact: Ming-Lung Yu, MD, PhD 886 7 3208282 fishya@ms14.hinet.net; fish6069@gmail.com | |
Principal Investigator: Ming-Lung Yu, MD.PhD |
Principal Investigator: | Ming-Lung Yu, MD, PhD | Kaohsiung Medical University |
Responsible Party: | Kaohsiung Medical University Hospital ( MING-LUNG YU ) |
Study ID Numbers: | KMUH-IRB-960057 |
Study First Received: | October 5, 2007 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00540345 History of Changes |
Health Authority: | Taiwan: Department of Health |
chronic hepatitis C genotype 2 rapid virological response sustained virological response |
peginterferon ribavirin treatment duration |
Antimetabolites Interferon-alpha Anti-Infective Agents Interferon Type I, Recombinant Liver Diseases Immunologic Factors Hepatitis, Chronic Ribavirin Interferons Hepatitis, Viral, Human |
Angiogenesis Inhibitors Antiviral Agents Hepatitis Virus Diseases Digestive System Diseases Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents Interferon Type I, Recombinant Liver Diseases Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Hepatitis, Chronic Immunologic Factors Antineoplastic Agents Ribavirin Physiological Effects of Drugs Hepatitis, Viral, Human Therapeutic Uses Growth Inhibitors Hepatitis C |
Angiogenesis Modulating Agents Interferon-alpha RNA Virus Infections Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Peginterferon alfa-2a Interferon Alfa-2a Hepatitis C, Chronic |