UMIN ID: UMIN000001034
Registered date:29/02/2008
A prospective cohort study of peginterferon alpha-2a plus ribavirin treatment in patients with chronic hepatitis C.
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Chronic hepatitis C |
Date of first enrollment | 2007/12/01 |
Target sample size | 200 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Combination therapy of peginterferon alpha-2a plus ribavirin. |
Outcome(s)
Primary Outcome | Negative results of qualitative HCV RNA test at weeks 4, 12, 24, and 48 during treatment and 24 weeks after terminating therapy. |
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Secondary Outcome | 1. Normalization of alanine aminotransferase levels at weeks 24 and 48 during treatment and 24 weeks after terminating therapy. 2. Adverse event and laboratory abnormality (changes in neutrophil count, platelet count, and hemoglobin concentration). 3. The incidence rates of completion of therapy, dose reduction, and discontinuation of therapy. 4. HCV Core and NS5A ISDR amino acid replacement and virological response. |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1. Pregnant or under breast feeding. 2. Allergic to ribavirin or other nucleoside preparations. 3. Uncontrolled cardiovascular diseases. 4. Abnormal hemoglobinemia. 5. Chronic renal failure or creatinine clearance value less than 50 mL/min. 6. Depression or psychiatric disorders. 7. Sever or decompensated liver disease. 8. Autoimmune liver diseases. 9. White blood cell count <3,000/microL, neutrophil count <1,500/microL, platelet count <90,000/microL, or hemoglobin concentration <12 g/dL. 10. Allergic to pegylated interferon alpha-2a or other interferon preparations. 11. Allergic to vaccine or biological preparations. 12. Concomitant herbal medication such as Sho-saiko-to. 13. Other conditions considered inappropriate by attending physician. |
Related Information
Primary Sponsor | Okayama University Hospital |
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Secondary Sponsor | |
Source(s) of Monetary Support | None |
Secondary ID(s) |
Contact
public contact | |
Name | Yoshiaki Iwasaki |
Address | 2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan Japan |
Telephone | 086-235-7219 |
Affiliation | Okayama University Hospital Department of Gastroenterology and Hepatology |
scientific contact | |
Name | Yoshiaki Iwasaki |
Address | 2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan Japan |
Telephone | 086-235-7219 |
Affiliation | Okayama University Hospital Department of Gastroenterology and Hepatology |