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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: | NCT00629967 |
The purposes of this study are:
Condition | Intervention | Phase |
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Chronic Hepatitis C Genotype |
Drug: pegylated interferon alpha 2a and ribavirin Drug: Pegylated interferon alfa-2a and ribavirin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open Labeled, Active-Controlled Trial of 24-Week Versus 48-Week Courses of Peg-Interferon Alpha Plus Ribavirin for Genotype-1 Infected Chronic Hepatitis C Patients |
Enrollment: | 200 |
Study Start Date: | April 2005 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Eligible patients 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 ribavirin
pegylated interferon alpha 2a 180 mcg/week and ribavirin 1000-1200 mg/day for 48 weeks
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B: Active Comparator
Eligible patients 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 24 weeks, follow up for 24 weeks
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Peginterferon and ribavirin combination treatment has been recommended for all patients infected with HCV, but the treatment duration varies depending on the HCV genotype. Recommended treatment for patients with HCV-1 infection is pegylated interferon plus ribavirin for 48 weeks and 24 weeks for HCV-2/3. A RVR is a strong predictor of SVR. Previous studies have demonstrated that for HCV-2/3 patients who had a RVR, a shorter duration of treatment with peginterferon plus standard dose of ribavirin over 14 weeks is as effective as a 24-week treatment regimen. These findings have questioned whether shorter treatment duration can yield high SVR rates for HCV-1 pts with an RVR.
The primary aim of the present study is to evaluate whether treatment with peginterferon and ribavirin for 24 weeks is sufficient to achieve an SVR rate comparable to that observed with the standard treatment duration of 48 weeks, in HCV-1 patients achieving an RVR at 4 weeks.
The secondary aim is to investigate the role of on-treatment virologic responses among patients with 24 or 48 weeks treatment.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Taiwan | |
Kaohsiung Medical University Hospital | |
Kaohsiung, Taiwan, 807 |
Principal Investigator: | Ming-Lung Yu, MD, PhD | Kaohsiung Medical University |
Principal Investigator: | Chia-Yen Dai, MD, Ms | Kaohsiung Municipal Hsiao-Kang Hospital |
Principal Investigator: | Chang-Fu Chiu, MD | Paochien Hospital |
Principal Investigator: | Jee-Fu Huang, MD | Foo Yin Hospital |
Responsible Party: | Kaohsiung Medical University Hospital ( MING-LUNG YU ) |
Study ID Numbers: | KMUH-IRB-94045 |
Study First Received: | February 26, 2008 |
Last Updated: | February 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00629967 |
Health Authority: | Taiwan: Department of Health |
chronic hepatitis C genotype 1 rapid virological response sustained virological response |
peginterferon ribavirin treatment duration |
Interferon-alpha Interferon Type I, Recombinant 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 Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Immunologic Factors Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |