Unique ID issued by UMIN | UMIN000012384 |
---|---|
Receipt number | R000014481 |
Scientific Title | Efficacy and safety of simeprevir/pegylated interferon/ribavirin for patients with HCV |
Date of disclosure of the study information | 2013/12/01 |
Last modified on | 2016/05/25 19:37:32 |
Efficacy and safety of simeprevir/pegylated interferon/ribavirin for patients with HCV
SMV RCT study
Efficacy and safety of simeprevir/pegylated interferon/ribavirin for patients with HCV
SMV RCT study
Japan |
Chronic liver disorder infected with hepatitis C
virus
Hepato-biliary-pancreatic medicine |
Others
YES
Evaluation of two pegylated interferons in combination therapy with simprevir and ribavirin
Safety,Efficacy
Eradication of hepatitis C
virus
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Simeprevir, RIbavirin, Pegylated interferon alpha 2a
Simeprevir, RIbavirin, Pegylated interferon alpha 2b
20 | years-old | <= |
Not applicable |
Male and Female
Patients with more than 5 Log copies/ml of genotype 1 HCV
pregnant woman
Uncontrolled heart diseases
Chronic renal failure
Depression
Hepatic cirrhosis
Hepatocellular carcinoma
Autoimmune hepatitis
Drug allergy for ribavirin, interferon, and simeprevir
400
1st name | |
Middle name | |
Last name | Akihiro Tamori |
Osaka City University Graduate School of Medicine
Department of Hepatology
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
06-6645-3811
atamori@med.osaka-cu.ac.jp
1st name | |
Middle name | |
Last name | Akihiro Tamori |
Osaka City University Graduate School of Medicine
Department of Hepatology
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
06-6645-3435
atamori@med.osaka-cu.ac.jp
Osaka City University Graduate School of Medicine
Osaka City University Graduate School of Medicine
Other
NO
2013 | Year | 12 | Month | 01 | Day |
Published
In total, 151 patients were randomly assigned to the P2aR (n = 76) or P2bR group (n = 75). Peginterferon alpha-2a or alpha-2b in combination with SMV + ribavirin therapy showed identical antiviral effects in patients with chronic hepatitis C. Also, the incidence of adverse events was identical for both regimens.
Completed
2013 | Year | 10 | Month | 30 | Day |
2013 | Year | 12 | Month | 20 | Day |
2013 | Year | 11 | Month | 22 | Day |
2016 | Year | 05 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014481
Research Plan | |
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Registered date | File name |
2016/05/25 | TMC倫理委員会実施計画書第3版.docx |
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Research case data | |
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