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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: | NCT00630084 |
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 chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma deserve to be elucidated.
The purposes of this study are:
Condition | Intervention | Phase |
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Chronic Hepatitis C Neoplasms |
Drug: pegylated interferon alpha 2a and plus ribavirin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Response and Outcomes of Pegylated Interferon Plus Ribavirin Combination Therapy for Chronic Hepatitis C Patients Concomitant With Malignancy Other Than Hepatocellular Carcinoma |
Estimated Enrollment: | 120 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
40 naïve CHC patients concomitant with malignancy other than hepatocellular carcinoma
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Drug: pegylated interferon alpha 2a and plus ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
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B: Active Comparator
80 naïve CHC patients without malignancy
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Drug: pegylated interferon alpha 2a and plus ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
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A prospective, hospital-based study enrolling 40 chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma and other sex- and age-matched 80 chronic hepatitis C patients without malignancy will be conducted. The 40 chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma will receive pegylated interferon-alpha 2a plus ribavirin combination therapy at remission phase after oncological treatments and/or interventions. The other 80 chronic hepatitis C patients without malignancy receiving the same antiviral therapy will serve as controls. The primary outcome measurement is sustained virological response and safety, whilst the secondary measurement is rapid virological and early virological response.
Ages Eligible for Study: | 18 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 |
Responsible Party: | Kaoshing Medical University Chung-Ho Memorial Hospital ( Ming-Lung Yu MD., PhD. ) |
Study ID Numbers: | KMUH-IRB-960044 |
Study First Received: | February 26, 2008 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00630084 |
Health Authority: | Taiwan: Department of Health |
chronic hepatitis C sustained virological response peginterferon ribavirin neoplasms |
Interferon-alpha Interferon Type I, Recombinant Liver Diseases Digestive System Neoplasms Hepatitis, Chronic Carcinoma, Hepatocellular Interferons Ribavirin Liver neoplasms Hepatitis, Viral, Human Carcinoma Hepatitis |
Virus Diseases Liver Neoplasms Digestive System Diseases Peginterferon alfa-2a Gastrointestinal Neoplasms Hepatitis C Interferon Alfa-2a Adenocarcinoma Hepatitis C, Chronic Hepatocellular carcinoma Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents RNA Virus Infections Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Immunologic Factors Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |