Unique ID issued by UMIN | UMIN000001034 |
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Receipt number | R000001205 |
Scientific Title | A prospective cohort study of peginterferon alpha-2a plus ribavirin treatment in patients with chronic hepatitis C. |
Date of disclosure of the study information | 2008/02/29 |
Last modified on | 2011/08/22 10:06:39 |
A prospective cohort study of peginterferon alpha-2a plus ribavirin treatment in patients with chronic hepatitis C.
A prospective study of peginterferon alpha-2a plus ribavirin for chronic hepatitis C.
A prospective cohort study of peginterferon alpha-2a plus ribavirin treatment in patients with chronic hepatitis C.
A prospective study of peginterferon alpha-2a plus ribavirin for chronic hepatitis C.
Japan |
Chronic hepatitis C
Hepato-biliary-pancreatic medicine |
Others
NO
To evaluate prospectively the efficacy and safety of peginterferon alpha-2a plus ribavirin in patients with chronic hepatitis C.
Safety,Efficacy
Negative results of qualitative HCV RNA test at weeks 4, 12, 24, and 48 during treatment and 24 weeks after terminating therapy.
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Combination therapy of peginterferon alpha-2a plus ribavirin.
20 | years-old | <= |
Not applicable |
Male and Female
Patients with HCV serogroup 1 (Genotype 1a or 1b) and high viral load (HCV RNA >= 100 KIU/mL) or non-responders or relapsers to the previous standard interferon monotherapy.
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.
200
1st name | |
Middle name | |
Last name | Yoshiaki Iwasaki |
Okayama University Hospital
Department of Gastroenterology and Hepatology
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
086-235-7219
1st name | |
Middle name | |
Last name | Yoshiaki Iwasaki |
Okayama University Hospital
Department of Gastroenterology and Hepatology
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
086-235-7219
Okayama University Hospital
None
Self funding
NO
2008 | Year | 02 | Month | 29 | Day |
Partially published
Completed
2007 | Year | 09 | Month | 26 | Day |
2007 | Year | 12 | Month | 01 | Day |
2011 | Year | 06 | Month | 01 | Day |
2008 | Year | 02 | Month | 14 | Day |
2011 | Year | 08 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001205
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