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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
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.

TO Original Data: UMIN

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.
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.

Primary Outcome

Negative results of qualitative HCV RNA test at weeks 4, 12, 24, and 48 during treatment and 24 weeks after terminating therapy.

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
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
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
E-mail
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
E-mail
Affiliation	Okayama University Hospital Department of Gastroenterology and Hepatology

TO Original Data: UMIN