UMIN ID: UMIN000001067
Registered date:31/03/2008
An open-label, randomized, controlled study of treatment duration of peginterferon alpha-2a monotherapy 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 with genotype 2a/2b or genotype 1b and low viral load (< 100 KIU/mL) |
Date of first enrollment | 2004/03/01 |
Target sample size | 270 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | PEG-IFN alpha-2a weekly for 24 weeks in patients with negative results of HCV RNA test at week 4 of therapy (Group A) PEG-IFN alpha-2a weekly for 48 weeks in patients with negative results of HCV RNA test at week 4 of therapy (Group B) PEG-IFN alpha-2a weekly for 48 weeks in patients with positive results of HCV RNA test at week 4 of therapy (Group C) |
Outcome(s)
Primary Outcome | Negative results of qualitative HCV RNA test at 24 weeks after terminating therapy |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 18years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | The following patients were excluded. 1. Concomitant herbal medication of Sho-saiko-to 2. Autoimmune hepatitis, alcoholic liver injury, or chronic liver diseases with other underlying causes 3. Allergic to pegylated interferon alpha-2a or other interferon preparations 4. Allergic to vaccine or biological preparations 5. Liver cirrhosis, decompensated liver disease, hepatocellular carcinoma, or other malignant diseases 6. Depression or psychiatric disorders 7. Other conditions considered inappropriate by attending physician |
Related Information
Primary Sponsor | Japanese Consortium for the Study of Liver Diseases |
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Secondary Sponsor | |
Source(s) of Monetary Support | None |
Secondary ID(s) |
Contact
public contact | |
Name | Yoshiaki Iwasaki |
Address | Japan |
Telephone | 086-235-7219 |
Affiliation | Okayama University Hospital Department of Gastroenterology and Hepatology |
scientific contact | |
Name | Masao Omata |
Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan Japan |
Telephone | |
Affiliation | University of Tokyo Department of Gastroenterology, Faculty of Medicine |