Unique ID issued by UMIN | C000000402 |
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Receipt number | R000000490 |
Scientific Title | A randomized, controlled study comparing the efficacy of peginterferon alfa-2b plus standard or reduced dose ribavirin in serotype 2 chronic hepatitis C |
Date of disclosure of the study information | 2006/04/17 |
Last modified on | 2011/10/11 08:25:16 |
A randomized, controlled study comparing the efficacy of peginterferon alfa-2b plus standard or reduced dose ribavirin in serotype 2 chronic hepatitis C
Shonan-Tokai Interferon Research for Serogroup 2 (STIRS2)
A randomized, controlled study comparing the efficacy of peginterferon alfa-2b plus standard or reduced dose ribavirin in serotype 2 chronic hepatitis C
Shonan-Tokai Interferon Research for Serogroup 2 (STIRS2)
Japan |
serotype 2 chronic hepatitis C
Hepato-biliary-pancreatic medicine |
Others
NO
To compare the efficacy of peginterferon alfa-2b plus standard or reduced dose ribavirin in serotype 2 chronic hepatitis C
Safety,Efficacy
sustained viral response (negative HCV-RNA 24 weeks after the end of treatment)
(1) percentage of patients in whom drug dose is reduced or treatment is discontinued (2) change in Hgb levels
Interventional
Parallel
Randomized
Open -no one is blinded
Dose comparison
NO
YES
2
Treatment
Medicine |
PEG-IFN alpha-2b (1.5ug/kg) + reduced dose ribavirin (400-800 mg)
PEG-IFN alpha-2b (1.5ug/kg) + standard dose ribavirin (600-1,000mg)
20 | years-old | <= |
Not applicable |
Male and Female
(1) genotype 2 chronic hepatitis C (2) patients with viral loads of 100 KIU/mL or more, or patients who did not respond to IFN monotherapy (3) patients satisfying below criteria within 30 days before entry (3-1) leukocyte count with 4000/mm3 or greater (3-2) neutrophil count with 1500/mm3 or greater (3-3) platelet count with 100000/mm3 or greater (3-4) hemoglobin level with 12.0 g/dl or greater
(1) pregnant women (2) patients allergic to ribavirin or IFN (3) patients with uncontrolled heart diseases (4) patients with abnormal hemoglobin (5) patients with chronic renal diseases (6) patients with severe depression or mental illness (7) patinets with liver cirrhosis or liver failure (8) patients who can not discontinue other antiviral or immunomodulating drugs
120
1st name | |
Middle name | |
Last name | Mine, Tetsuya |
Tokai University School of Medicine
Gastroenterology
Boseidai, Isehara, Japan
1st name | |
Middle name | |
Last name | Kagawa, Tatehiro |
Tokai University School of Medicine
Gastroenterology
0463-93-1121
kagawa@is.icc.u-tokai.ac.jp
Tokai University School of Medicine
Tokai University School of Medicine, Department of Gastroenterology
Self funding
NO
2006 | Year | 04 | Month | 17 | Day |
Unpublished
Completed
2006 | Year | 04 | Month | 04 | Day |
2006 | Year | 04 | Month | 01 | Day |
2010 | Year | 08 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2006 | Year | 04 | Month | 10 | Day |
2011 | Year | 10 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000490
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