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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: | NCT00629824 |
Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its impact on the outcome in older patients with chronic hepatitis C deserve to be elucidated.
The purposes of this study are:
Condition | Intervention | Phase |
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Chronic Hepatitis C |
Drug: pegylated interferon alpha and plus ribavirin Drug: pegylated interferon alpha and plus ribavirin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Pegylated Interferon Plus Ribavirin Combination Therapy in Treating Older Patients With Chronic Hepatitis C |
Estimated Enrollment: | 250 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
110 naïve CHC patients who are 65 to 80 years of age
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Drug: pegylated interferon alpha and plus ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day, 24weeks of treatment for genotype non-1 infected patients and 48 weeks of treatment for genotype 1 infected patients, follow up for 24 weeks
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B: Active Comparator
140 naïve CHC patients who are 50 to 64 years of age
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Drug: pegylated interferon alpha and plus ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day, 24weeks of treatment for genotype non-1 infected patients and 48 weeks of treatment for genotype 1 infected patients, follow up for 24 weeks
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C: Active Comparator
40 HCV-1 infected patients with an RVR who are 65-80 years of age will receive 24 weeks of treatment
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Drug: pegylated interferon alpha and plus ribavirin
pegylated interferon alpha 180 ug/week and ribavirin 1000-1200 mg/day for 24 weeks
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A prospective, hospital-based, case-control study enrolling 70 chronic hepatitis C patients who are 65 to 80 years of age and other sex- and HCV genotype-matched 140 chronic hepatitis C patients who are 50 to 64 years of age will be conducted for comparison. The 210 patients chronic hepatitis C patients will receive pegylated interferon-alpha plus ribavirin combination therapy. Genotype 1 infected patients will received 48 weeks of treatment and genotype non-1 patients will received 24 weeks of treatment. Another 40 HCV-1 infected patients who are 65-80 years of age and have a rapid virological response ( defined as seronegative of HCV RNA at week 4 of treatment) will receive 24 weeks of treatment and are enrolled for comparison since Jan 2008. The primary outcome measurement is sustained virological response and safety.
Ages Eligible for Study: | 50 Years to 80 Years |
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 |
Principal Investigator: | Jee-Fu Huang, MD | Kaohsiung Municipal Hsiao-Kang Hospital |
Responsible Party: | Kaohsiung Medical University Hospital ( Ming-Lung Yu ) |
Study ID Numbers: | KMUH-IRB- 960047 |
Study First Received: | February 26, 2008 |
Last Updated: | January 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00629824 |
Health Authority: | Taiwan: Department of Health |
chronic hepatitis C sustained virological response rapid virological response |
peginterferon ribavirin old age |
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 |