Unique ID issued by UMIN | UMIN000012668 |
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Receipt number | R000014812 |
Scientific Title | Efficacy and safety of simeprevir plus pegylated intereferon combination therapy for HCV genotype 1 patients with chronic renal failure |
Date of disclosure of the study information | 2013/12/25 |
Last modified on | 2017/06/29 17:49:30 |
Efficacy and safety of simeprevir plus pegylated intereferon combination therapy for HCV genotype 1 patients with chronic renal failure
Simeprevir plus pegylated intereferon combination therapy for HCV genotype 1 patients with chronic renal failure
Efficacy and safety of simeprevir plus pegylated intereferon combination therapy for HCV genotype 1 patients with chronic renal failure
Simeprevir plus pegylated intereferon combination therapy for HCV genotype 1 patients with chronic renal failure
Japan |
chronic infection with hepatitis C virus
Hepato-biliary-pancreatic medicine |
Others
NO
Investigating sustained virological response rate (the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment) of Simeprevir plus Peg-IFN combination therapy in HCV genotype 1 patients with chronic renal failure.
Safety,Efficacy
- Investigating sustained virological response rate (the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment) of Simeprevir plus Peg-IFN combination therapy in HCV genotype 1 patients with chronic renal failure.
- Investigating the factors for sustained virological response.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Simeprevir plus Peg-IFN combination therapy
20 | years-old | <= |
Not applicable |
Male and Female
1) Hemodialysis patients
2) Patients with chronic infection with hepatitis C virus genotype 1 and more than 5 log IU/ml
1) Patients with co-infection with hepatitis B virus or human immunodeficiency virus or alcoholic liver disorder or autoimmune hepatitis.
2) Patients with uncompensated cirrhosis or hepatic failure
3) Patients with multiple organ failure or immunological deficiency
4) Patients with severe depression or past history of psychiatric disorder
5) Patients in pregnancy or lactating or patients who expect to become pregnant
45
1st name | |
Middle name | |
Last name | Tetsuo Takehara |
Osaka University Graduate school of Medicine
Department of Gastroenterology and Hepatology
Yamadaoka 2-2, Suita, Osaka, Japan
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Naoki Hiramatsu |
Osaka University Graduate school of Medicine
Gastroenterology and Hepatology
Yamadaoka 2-2, Suita, Osaka, Japan
06-6879-3621
hiramatsu@gh.med.osaka-u.ac.jp
Osaka University Graduate school of Medicine
Osaka University Graduate school of Medicine
Self funding
NO
2013 | Year | 12 | Month | 25 | Day |
Unpublished
Completed
2013 | Year | 11 | Month | 05 | Day |
2013 | Year | 12 | Month | 25 | Day |
2013 | Year | 12 | Month | 24 | Day |
2017 | Year | 06 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014812
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