Early Prediction of Successful Treatment for Chronic Hepatitis C Virus Infection in Taiwan
Recruitment status was Recruiting
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Purpose
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 |
|---|---|
|
Chronic Hepatitis C |
Drug: Pegylated interferon alfa and ribavirin |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Early Prediction of Successful Treatment for Chronic Hepatitis C Virus Infection in Taiwan |
- Sustained virologic response (SVR) [ Time Frame: 1~1.5 years ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
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)
|
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) Other Names:
|
Detailed Description:
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.
Eligibility| 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:
- Treatment naïve
- Over 18 years old
- Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months
- Detectable serum quantitative HCV-RNA (Cobas Amplicor HCV Monitor v2.0, Roche Molecular Systems, Pleasanton, CA) with dynamic range 600~< 500,000 IU/ml
- Serum alanine aminotransferase levels above the upper limit of normal with 6 months of enrollment
- A liver biopsy consistent with the diagnosis of chronic hepatitis C
Exclusion Criteria:
- Anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
- Neutropenia (neutrophil count < 1,500 per cubic milliliter)
- Thrombocytopenia (platelet < 90,000 per cubic milliliter)
- Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Chronic alcohol abuse (daily consumption > 20 gram per day)
- Decompensated liver disease (Child-Pugh class B or C)
- Serum creatinine level more than 1.5 times the upper limit of normal
- Autoimmune liver disease
- Neoplastic disease
- An organ transplant
- Immunosuppressive therapy
- Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
- Evidence of drug abuse
- Unwilling to have contraception
- Unwilling to receive serial blood sampling during the study
Contacts and Locations| 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, Yun-Lin Branch | Recruiting |
| Douliou, Taiwan | |
| Principal Investigator: Shih-Jer Hsu, 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 | |
| Buddhist Tzu Chi General Hospital | Recruiting |
| Taipei, Taiwan | |
| Principal Investigator: Ching-Sheng Hsu, MD | |
| Sub-Investigator: Chia-Chi Wang, MD | |
| Far Eastern Memorial Hospital | Recruiting |
| Taipei, Taiwan | |
| Principal Investigator: Cheng-Chao Liang, MD | |
| 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 | |
| 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 |
More Information
Publications:
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00543244 History of Changes |
| Other Study ID Numbers: | 200709053R |
| Study First Received: | October 10, 2007 |
| Last Updated: | November 20, 2008 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Chronic hepatitis C Pegylated interferon Ribavirin Virokinetics |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Virus Diseases Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2a |
Interferons Ribavirin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013