NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000015229

Registered date:01/10/2014

Open-label, randomized, controlled study peginterferon alpa-2b plus dose-escalation of ribavirin in patients with chronic hepatitis C

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedChronic hepatitis C
Date of first enrollment2006/01/01
Target sample size380
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Standard therapy of 48 weeks according to package insert of peginterferon alpha 2b plus ribavirin Starting with lower dose of ribavirin than standard dose according to package insert by 200 mg in combination with peginterferon alpha-2b, followed by dose-escalation of ribavirin by 100 mg, when hemoglobin concentration maintained at or above 12 g/dL at week 4 an 8

Outcome(s)

Primary OutcomeRate of negative results of qualitative HCV RNA test (end-of-treatment and 24 weeks after terminating therapy
Secondary Outcome1. Sustained virological response rate accordong to the time point of viral disappearance 2. Rate of anemia (defined as hemoglobin concentration < 10 g/dL) at every week up to week 8 and every 4 weeks therafter 3. Incidence of dose modification and discontinuation of therapy

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1. Hemoglobin values at entry visit less than 12 g/dL 2. Allergic to interferon or vaccine preparations 3. Allergic to ribavirin or other nucleos(t)ide preparations 4. Pregnant or under breast feeding 5. Uncontrolled cardiovascular diseases 6. Abnormal hemoglobinemia 7. Chronic renal failure or creatinine clearance value less than 50 mL/min 8. Neurologic or psychiatric disease 9. Sever or decompensated liver disease 10. Hypertension or diabetes 11. History of apoplexy 12. Autoimmune hepatitis 13. Chronic hepatitis B or excessive daily intake of alcohol 14. Concomitant immunosuppressive or herbal medication such as Sho-saiko-to 15. Other conditions considered inappropriate by attending physician

Related Information

Contact

public contact
Name Yoshiaki Iwasaki
Address 2-5-1, Shikata-cho, Okayama-city, Okayama, Japan Japan
Telephone 086-235-7219
E-mail yiwasaki@cc.okayama-u.ac.jp
Affiliation Okayama University Hospital Department of Gastroenterology and Hepatology
scientific contact
Name Yoshiaki Iwasaki
Address 2-5-1, Shikata-cho, Okayama-city, Okayama, Japan Japan
Telephone 086-235-7219
E-mail yiwasaki@cc.okayama-u.ac.jp
Affiliation Okayama University Hospital Department of Gastroenterology and Hepatology