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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: | NCT00543244 |
Hepatitis C virus (HCV) infection is a global health problem, which may lead to chronic hepatitis, cirrhosis, hepatic decompensation and hepatocellular carcinoma (HCC). Recently, treatment with peginterferon alfa plus ribavirin has become the standard of care for patients with chronic hepatitis C. While genotype 2 patients can have higher sustained virologic response (SVR) rates to 80-90%, genotype 1 patients generally have low SVR rates of only 40-50%. In contrast, genotype 1 Taiwanese patients have superior SVR rates than those in Western countries. Despite the overall improved response to this combination therapy, more than 75% of patients suffer from treatment-related adverse events and the costs remain high, which make individualized therapy of paramount importance to maximize treatment response and minimize adverse events.
HCV viral kinetics with interferon-based therapies have been studied recently to evaluate patient responses. Early viral kinetics shown to have favorable SVR rates, which make shorter treatment duration possible. However, different viral kinetics were found through ethnicity. Recently, a pilot study to evaluate the viral kinetics of 6 Taiwanese patients with HCV infection who received peginterferon alfa plus ribavirin therapy has shown superior early viral kinetics to those in Caucasian patients. Based on the favorable SVR rates in treating Taiwanese patients with chronic hepatitis C, the investigators aimed to conduct a large confirmatory study to evaluate the viral kinetics and try to define the optimal treatment for these patients.
Condition | Intervention |
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Chronic Hepatitis C |
Drug: Pegylated interferon alfa and ribavirin |
Study Type: | Observational |
Study Design: | Case-Only, Cross-Sectional |
Official Title: | Early Prediction of Successful Treatment for Chronic Hepatitis C Virus Infection in Taiwan |
Estimated Enrollment: | 300 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Patients with chronic hepatitis C who receive pegylated interferon plus ribavirin for 24 weeks (genotype 1 or 2) and for 48 weeks (genotype 1)
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Drug: Pegylated interferon alfa and ribavirin
Pegylated interferon alfa-2a 180 ug/week or pegylated interferon alfa-2b 1.5 ug/kg/week Ribavrin 800-1200 mg/day (genotype 1: < 75 kg 1000 mg/day, >=75 kg 1200 mg/day; genotype 2: 800 mg/day) HCV genotype: baseline (Day 0) HCV RNA (real time PCR test): baseline (Day 0), Day 1 (4,8,12 hours after pegylated interferon + ribavirin), Day 2 (24,36 hours), Day 3(48 hours), Day 4 (72 hours), Day 5 (96 hours), Week 2,4,6,8,12,16,20,24, and 28,32,36,40,44,48,72 (for genotype 1 with 48 weeks of treatment), and 48 (for genotype 1 or 2 with 24 weeks of treatment) |
Hepatitis C virus (HCV) infection is a global health problem, which may lead to chronic hepatitis, cirrhosis, hepatic decompensation and hepatocellular carcinoma (HCC). [1,2] Recently, treatment with peginterferon alfa plus ribavirin has become the standard of care for patients with chronic hepatitis C. While genotype 2 patients can have higher sustained virologic response (SVR) rates to 80-90%, genotype 1 patients generally have low SVR rates of only 40-50%. [3-5] In contrast, genotype 1 Taiwanese patients have superior SVR rates that those in Western countries. [6,7] Despite the overall improved response to this combination therapy, more than 75% of patients suffer from treatment-related adverse events and the costs remain high, [8,9] which make individualized therapy of paramount importance to maximize treatment response and minimize adverse events.
HCV viral kinetics with interferon-based therapies have been studied recently to evaluate patient responses. [10-14] Early viral kinetics shown to have favorable SVR rates, which make shorter treatment duration possible. [15-18] However, different viral kinetics were found through ethnicity. [19-23] Recently, a pilot study to evaluate the viral kinetics of 6 Taiwanese patients with HCV infection who received peginterferon alfa plus ribavirin therapy has shown superior early viral kinetics to those in Caucasian patients. [24] Based on the favorable SVR rates in treating Taiwanese patients with chronic hepatitis C, the investigators aimed to conduct a large confirmatory study to evaluate the viral kinetics and try to define the optimal treatment for these patients.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients with chronic hepatitis C virus infection who receive pegylated interferon plus ribavirin for an overall of 24-48 weeks
Inclusion Criteria:
Exclusion Criteria:
Contact: Jia-Horng Kao, MD, PhD | 886-2-23123456 ext 7307 | kaojh@ntu.edu.tw |
Contact: Avidan Uriel Neumann, PhD | 972-3-531-7970 | neumann@mail.biu.ac.il |
Israel | |
Faculty of Life Sciences, Bar-Ilan University | Recruiting |
Ramat-Gan, Israel | |
Principal Investigator: Avidan Uriel Neumann, MD, PhD | |
Taiwan | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan, 100 | |
Principal Investigator: Jia-Horng Kao, MD, PhD | |
Sub-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 | |
Sub-Investigator: Chun-Jen Liu, MD,PhD | |
Far Eastern Memorial Hospital | Recruiting |
Taipei, Taiwan | |
Principal Investigator: Cheng-Chao Liang, MD | |
National Taiwan University Hospital, Yun-Lin Branch | Recruiting |
Douliou, Taiwan | |
Principal Investigator: Shih-Jer Hsu, MD | |
Buddhist Tzu Chi General Hospital | Recruiting |
Taipei, Taiwan | |
Principal Investigator: Ching-Sheng Hsu, MD | |
Sub-Investigator: Chia-Chi Wang, MD | |
Taichung Veterans General Hospital | Recruiting |
Taichung, Taiwan | |
Principal Investigator: Sheng-Shun Yang, 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 |
Principal Investigator: | Avidan Uriel Neumann, PhD | Faculty of Life Sciences, Bar-Ilan University, Ramat-Gan, Israel |
Principal Investigator: | Chen-Hua Liu, MD | National Taiwan University Hospital |
Responsible Party: | National Taiwan University Hospital ( National Taiwan University Hospital ) |
Study ID Numbers: | 200709053R |
Study First Received: | October 10, 2007 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00543244 |
Health Authority: | Taiwan: Department of Health |
Chronic hepatitis C Pegylated interferon Ribavirin Virokinetics |
Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Ribavirin Hepatitis, Viral, Human 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 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 |