NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedChronic hepatitis C with genotype 2a/2b or genotype 1b and low viral load (< 100 KIU/mL)
Date of first enrollment2004/03/01
Target sample size270
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeNegative results of qualitative HCV RNA test at 24 weeks after terminating therapy
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaThe 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

Contact

public contact
Name Yoshiaki Iwasaki
Address Japan
Telephone 086-235-7219
E-mail
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
E-mail
Affiliation University of Tokyo Department of Gastroenterology, Faculty of Medicine