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Sponsors and Collaborators: |
National Taiwan University Hospital National Science Council, Taiwan Department of Health, Taiwan |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00532701 |
Treatment with peginterferon plus daily low dose (800 mg) or weight-based ribavirin (800-1400 mg) for 24 to 48 weeks has achieved 70-93% sustained virologic response (SVR) rates in patients with genotype 2 or 3 chronic hepatitis C (CHC). Recently, a large randomized study has shown that patients with genotype 2 or 3 CHC have comparable SVR rates for those who received peginterferon for 24 or 48 weeks, and who received daily low dose (800 mg) or standard dose (1000-1200 mg) ribavirin. Therefore, the currently recommended treatment for these patients is 24 weeks of peginterferon plus low dose ribavirin. Because of the high response rates, several studies have shown that when these patients had rapid virologic response (RVR), defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% versus 79%) in these patients who achieved RVR. While studies showed concordant results in SVR rates for patients with genotype 3 CHC who received peginterferon plus low dose or weight-based ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in patients with genotype 2 CHC who received such treatment. Currently, there are no studies on the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of treatment stratified by RVR for patients with genotype 2 CHC. The investigators aimed to conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis C |
Drug: Pegylated interferon alfa-2a + ribavirin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Peginterferon Alfa-2a Plus Ribavirin in Patients With Genotype 2 Chronic Hepatitis C: A Randomized Study of Treatment Duration and Ribavirin Dose Stratified by Rapid Virologic Response |
Estimated Enrollment: | 700 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Weight-based ribavirin (1000-1200 mg/day) from weeks 1-16 in patients with RVR
|
Drug: Pegylated interferon alfa-2a + ribavirin
|
2: Active Comparator
Weight-based ribavirin (1000-1200 mg/day) from weeks 1-4, and then low dose ribavirin (800 mg/day) from weeks 5-16 in patients with RVR
|
Drug: Pegylated interferon alfa-2a + ribavirin
|
3: Active Comparator
Weight-based ribavirin (1000-1200 mg/day) from weeks 1-24 in patients without RVR
|
Drug: Pegylated interferon alfa-2a + ribavirin
|
4: Active Comparator
Weight-based ribavirin (1000-1200 mg/day) from weeks 1-48 in patients without RVR
|
Drug: Pegylated interferon alfa-2a + ribavirin
|
5: Active Comparator
Low dose ribavirin (800 mg/day) from weeks 1-24 in patients with or without RVR
|
Drug: Pegylated interferon alfa-2a + ribavirin
|
Treatment with peginterferon plus daily low dose (800 mg) or weight-based ribavirin (800-1400 mg) for 24 to 48 weeks has achieved 70-93% sustained virologic response (SVR) rates in patients with genotype 2 or 3 chronic hepatitis C (CHC). Recently, a large randomized study has shown that patients with genotype 2 or 3 CHC have comparable SVR rates for those who received peginterferon for 24 or 48 weeks, and who received daily low dose (800 mg) or standard dose (1000-1200 mg) ribavirin. Therefore, the currently recommended treatment for these patients is 24 weeks of peginterferon plus low dose ribavirin. Because of the high response rates, several studies have shown that when these patients had rapid virologic response (RVR), defined as undetectable hepatitis C virus (HCV) RNA levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% vs.
79%) in these patients who achieved RVR. While studies showed concordant results in SVR rates for patients with genotype 3 CHC who received peginterferon plus low dose or weight-based ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in patients with genotype 2 CHC who received such treatment. Currently, there are no studies on the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of treatment stratified by RVR for patients with genotype 2 CHC. We aimed to conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chen-Hua Liu, MD | +886-2-23123456 ext 3572 | jacque_liu@mail2000.com.tw |
Contact: Jia-Horng Kao, MD, PhD | +886-2-23123456 ext 7307 | kaojh@ntu.edu.tw |
Taiwan | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan, 100 | |
Principal Investigator: Chen-Hua Liu, MD | |
Principal Investigator: Jia-Horng Kao, MD, PhD | |
Principal Investigator: Ding-Shinn Chen, MD | |
Principal Investigator: Ming-Yang Lai, MD, PhD | |
Principal 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 | |
Ren-Ai Branch, Taipei Municipal Hospital | Recruiting |
Taipei, Taiwan | |
Principal Investigator: Chih-Lin Lin, MD | |
Paochien Hospital | Recruiting |
Pingtung, Taiwan | |
Contact: Chang-Fu Chiu, MD | |
Principal Investigator: Chang-Fu Chiu, MD | |
Taichung Veterans General Hospital | Recruiting |
Taichung, Taiwan | |
Principal Investigator: Sheng-Shun Yang, MD | |
Kaohsiung Medical University | Recruiting |
Kaohsiung, Taiwan | |
Contact: Ming-Lung Yu, MD, PhD | |
Principal Investigator: Ming-Lung Yu, MD, PhD | |
Principal Investigator: Wan-Long Chuang, MD, PhD | |
Kaohsiung Municipal Hsiao-Kang Hospital | Recruiting |
Kaohsiung, Taiwan | |
Contact: Chia-Yen Dai, MD, Ms | |
Principal Investigator: Chia-Yen Dai, MD, Ms | |
Principal Investigator: Jee-Fu Huang, MD | |
Buddhist Xindian Tzu Chi General Hospital | Recruiting |
Taipei, Taiwan | |
Principal Investigator: Ching-Sheng Hsu, MD | |
Principal Investigator: Chia-Chi Wang, MD | |
Principal Investigator: Tai-Chung Tseng, MD |
Principal Investigator: | Jia-Horng Kao, MD, PhD | National Taiwan University Hospital |
Principal Investigator: | Ding-Shinn Chen, MD | National Taiwan University Hospital |
Principal Investigator: | Ming-Yang Lai, MD, PhD | National Taiwan University Hospital |
Principal Investigator: | 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 Hospital, Yun-Lin Branch |
Principal Investigator: | Chih-Lin Lin, MD | Taipei City Hospital, Ren-Ai Branch |
Principal Investigator: | Cheng-Chao Liang, MD | Far Eastern Memorial Hospital |
Principal Investigator: | Ching-Sheng Hsu, MD | Buddhist Xindian Tzu Chi General Hospital |
Principal Investigator: | Sheng-Shun Yang, MD | Taichung Veterans General Hospital |
Principal Investigator: | Chia-Chi Wang, MD | Buddhist Xindian Tzu Chi General Hospital |
Principal Investigator: | Tai-Chung Tseng, MD | Buddhist Xindian Tzu Chi General Hospital |
Principal Investigator: | Ming-Lung Yu, MD, PhD | Kaohsiung Medical University |
Principal Investigator: | Wan-Long Chuang, MD, PhD | Kaohsiung Medical University |
Principal Investigator: | Chia-Yen Dai, MD, Ms | Kaohsiung Municipal Hsiao-Kang Hospital |
Principal Investigator: | Jee-Fu Huang, MD | Kaohsiung Municipal Hsiao-Kang Hospital |
Principal Investigator: | Chang-Fu Chiu, MD | Paochien Hospital |
Responsible Party: | National Taiwan University Hospital ( National Taiwan University Hospital ) |
Study ID Numbers: | 200709014M |
Study First Received: | September 18, 2007 |
Last Updated: | December 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00532701 History of Changes |
Health Authority: | Taiwan: Department of Health |
Chronic hepatitis C Genotype Interferon |
Ribavirin Genotype 2 Peginterferon |
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 |