Unique ID issued by UMIN | UMIN000000897 |
---|---|
Receipt number | R000000987 |
Scientific Title | A comparison of peginterferon ribavirin combination therapies for chronic hepatitis C |
Date of disclosure of the study information | 2007/11/17 |
Last modified on | 2013/12/21 18:57:12 |
A comparison of peginterferon ribavirin combination therapies for chronic hepatitis C
A comparison of peginterferon ribavirin combination therapies
A comparison of peginterferon ribavirin combination therapies for chronic hepatitis C
A comparison of peginterferon ribavirin combination therapies
Japan |
chronic hepatitis C with high viral load (>100KIU/ml) and serogroup I
Hepato-biliary-pancreatic medicine |
Others
NO
To compare peginterferon alfa-2b in combination with ribavirin versus
peginterferon alfa-2a in combination with ribavirin
Safety,Efficacy
SVR(sustained virologic response:no detectable hepatitis C virus in their blood 6 months after treatment has ended) rate
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
2
Treatment
Medicine |
peginterferon alfa-2b in combination with ribavirin
peginterferon alfa-2a in combination with ribavirin
20 | years-old | <= |
Not applicable |
Male and Female
The study is designed to enroll patients with HCV RNA positive.
1.Chronic hepatitis C
2.HCV RNA >=100KIU/ml
3.WBC >=3000/mm3
4.Neutrophil >=1500/mm3
5.Platelet count >=90,000
6.Hemoglobin >=12g/dL
7.Patient who was explained about the study, understood it, and gave the consent form
The exclusion criteria are as follows:
1.liver disease such as autoimmune hepatitis, coinfection with hepatitis B,
2.severe renal disease, Ccr <50ml/min
3.poorly controlled heart disease
4.depression or psychosomatic disorders
5.Sho-saiko-to treatment within 30 days before interferon administration
6.pregnant or lactating women and women who may be pregnant
7.a man who can not avoid conception during administration of ribavirin and until 6 month after the end ribavirin treatment
8.drug allergy against interferon or ribavirin
9.allergy against biological drugs
10.no prior therapy of peginterferon in combination with ribavirin
11.on other clinical trial
12.any reason which medical doctor regard the patient as unsuitable for this test
320
1st name | |
Middle name | |
Last name | Haruhiko Yoshida |
University of Tokyo
Department of Gastroenterology, Faculty of Medicine
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
03-3815-5411
yoshida-2im@h.u-tokyo.ac.jp
1st name | |
Middle name | |
Last name | Tadashi Goto |
University of Tokyo
Department of Gastroenterology, Faculty of Medicine
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
03-3815-5411
tadagotou-gi@umin.ac.jp
University of Tokyo
Department of Gastroenterology, Faculty of Medicine
None
Self funding
NO
2007 | Year | 11 | Month | 17 | Day |
Unpublished
Completed
2007 | Year | 09 | Month | 13 | Day |
2007 | Year | 11 | Month | 01 | Day |
2013 | Year | 11 | Month | 01 | Day |
2007 | Year | 11 | Month | 16 | Day |
2013 | Year | 12 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000987
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |