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Sponsors and Collaborators: |
National Taiwan University Hospital National Science Council, Taiwan |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00495131 |
Chronic hepatitis C virus (HCV) infection is prevalent in the world, affecting 3% of the world's population. The current standard of therapy is pegylated interferon and ribavirin, reaching 54-63% of successful rates. In patients with HCV genotype 1 infection, a 48 week course of combination therapy has achieved a higher successful rate that a 24 weeks course of therapy. However, several studies in Taiwan have shown that a 24 week course of therapy has comparable or even better response to a 48 week course of therapy in Western countries. Therefore, whether a 48 week course of therapy can achieve a higher response to a 24 week course of therapy in Taiwanese patients with genotype 1 HCV infection remains unclear.
Condition | Intervention | Phase |
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Chronic Hepatitis C |
Drug: Pegylated interferon alfa-2a plus ribavirin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus Genotype 1-Infected Patients in Taiwan |
Estimated Enrollment: | 300 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
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Drug: Pegylated interferon alfa-2a plus ribavirin
Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
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2: Active Comparator
Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
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Drug: Pegylated interferon alfa-2a plus ribavirin
Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
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Combination therapy with interferon alfa (IFN-α) plus ribavirin for 24 to 48 weeks produces sustained virologic response (SVR) rate in approximately 31-47% of treatment naïve patients with chronic hepatitis C.(1-5) Patients with genotype 1 virus infection are less likely to have SVR that those with other genotypes infection, and therefore, patients infected with hepatitis C virus (HCV) genotype 1 should receive treatment for 48 weeks.(6) Recently, combination therapy with pegylated interferon alfa (pegylated IFN-α) plus ribavirin produces higher SVR rates (54-56%) than that with IFN-α plus ribavirin.(7,8) Furthermore, a large trial assessing the effect and duration of pegylated IFN-α plus ribavirin showed that the overall SVR rate was 63%. Among patients with genotype 1 HCV infection, standard dose ribavirin (1000 to 1200 mg per day) and 48 weeks of treatment were significantly more effective than low dose ribavirin (800 mg per day) or 24 weeks of treatment.(9) The SVR rate was 51% for genotype 1 patients receiving pegylated IFN-α plus standard dose ribavirin for 48 weeks, whereas only 29% and 41% for those receiving pegylated IFN-α plus low dose ribavirin and standard dose ribavirin for 24 weeks, respectively. Based on these lines of evidence, 48 weeks of therapy with pegylated IFN-α (pegylated IFN-α 2a 180 μg or pegylated IFN-α 2b 1.5 μg per kilogram body weight weekly) plus ribavirin (1000 to 1200 mg per day) is recommended to treat patients with HCV genotype 1 infection.(10) In Taiwan, a multicenter study showed that a 6 month course treatment with pegylated IFN-α plus standard dose ribavirin had a comparable SVR rate to that with IFN-α plus standard dose ribavirin (67.1% versus 63.6%) in patients with chronic hepatitis C. Subgroup analysis showed that treatment with pegylated IFN-α plus standard dose ribavirin had a significantly higher SVR rate to that with IFN-α plus standard dose ribavirin (65.8% versus 41.0%) in patients with genotype 1 HCV infection.(11) Recently, a pilot study comparing 24 and 48 weeks of pegylated IFN-α plus standard dose ribavirin in patients with genotype 1 HCV infection showed that 48 weeks of treatment is more efficacious that 24 weeks of treatment (SVR rate: 80.0% versus 48.9%).(12) However, much difference of SVR rates occurred in these two studies, making optimal therapy in Taiwanese patients infected with genotype 1 HCV difficult to be determined. In the study, we aim to investigate in a large cohort whether 48 weeks treatment with pegylated IFN-α plus standard dose ribavirin is more efficacious than 24 weeks treatment in patients with genotype 1 HCV infection.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jia-Horng Kao, MD, PhD | +886-2-23123456 ext 7307 | kaojh@ntu.edu.tw |
Contact: Chen-Hua Liu, MD | +886-2-23123456 ext 3572 | jacque_liu@mail2000.com.tw |
Taiwan | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan, 100 | |
Principal Investigator: Jia-Horng Kao, MD, PhD | |
Principal Investigator: Chen-Hua Liu, MD | |
Sub-Investigator: Ding-Shinn Chen, MD | |
Sub-Investigator: Ming-Yang Lai, MD, PhD | |
Sub-Investigator: Pei-Jer Chen, MD, PhD | |
Principal Investigator: Chun-Jen Liu, MD,PhD | |
National Taiwan University Hospital, Yun-Lin Branch | Recruiting |
Douliou, Taiwan | |
Principal Investigator: Shih-Jer Hsu, MD | |
Far Eastern Memorial Hospital | Recruiting |
Taipei, Taiwan | |
Principal Investigator: Cheng-Chao Liang, MD | |
Taichung Veterans General Hospital | Recruiting |
Taichung, Taiwan | |
Principal Investigator: Sheng-Shun Yang, MD | |
Buddhist Tzu Chi General Hospital | Recruiting |
Taipei, Taiwan | |
Principal Investigator: Ching-Sheng Hsu, MD | |
Sub-Investigator: Chia-Chi Wang, MD | |
Sub-Investigator: Tai-Chung Tseng, MD | |
Ren-Ai Branch, Taipei Municipal Hospital | Recruiting |
Taipei, Taiwan | |
Principal Investigator: Chih-LIn Lin, MD |
Study Chair: | Jia-Horng Kao, MD, PhD | National Taiwan University Hospital |
Study Director: | Ding-Shinn Chen, MD | National Taiwan University Hospital |
Study Director: | Ming-Yang Lai, MD, PhD | National Taiwan University Hospital |
Study Director: | Pei-Jer Chen, MD, PhD | National Taiwan University Hospital |
Principal Investigator: | Chun-Jen Liu, MD, PhD | National Taiwan University Hospital |
Principal Investigator: | Chen-Hua Liu, MD | National Taiwan University Hospital |
Principal Investigator: | Shih-Jer Hsu, MD | National Taiwan University Hosptial, Yun-Lin Branch |
Principal Investigator: | Chih-Lin Lin, MD | Ren-Ai Branch, Taipei City Hospital |
Principal Investigator: | Cheng-Chao Liang, MD | Far Eastern Memorial Hospital |
Principal Investigator: | Ching-Sheng Hsu, MD | Buddhist Tzu Chi General Hospital |
Principal Investigator: | Sheng-Shun Yang, MD | Taichung Veterans General Hospital |
Responsible Party: | National Taiwan University Hospital ( National Taiwan University Hospital ) |
Study ID Numbers: | 200705080M |
Study First Received: | June 29, 2007 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00495131 History of Changes |
Health Authority: | Taiwan: Department of Health |
Chronic hepatitis C Genotype 1 Interferon Ribavirin |
Antimetabolites Interferon-alpha 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 |