Unique ID issued by UMIN | UMIN000013715 |
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Receipt number | R000016011 |
Scientific Title | Therapeutic effects of pegylated-interferon (Peg-IFN) therapy combined with ribavirin (RBV) and simeprevir on patients with chronic hepatitis C |
Date of disclosure of the study information | 2014/04/14 |
Last modified on | 2018/10/18 23:26:25 |
Therapeutic effects of pegylated-interferon (Peg-IFN) therapy combined with ribavirin (RBV) and simeprevir on patients with chronic hepatitis C
Investigation of the therapeutic effects regarding a new triple therapy for chronic hepatitis C
Therapeutic effects of pegylated-interferon (Peg-IFN) therapy combined with ribavirin (RBV) and simeprevir on patients with chronic hepatitis C
Investigation of the therapeutic effects regarding a new triple therapy for chronic hepatitis C
Japan |
Chronic hepatitis C
Hepato-biliary-pancreatic medicine |
Others
YES
Comparison of clinical effects between the two pegylated-interferons (-alpha2a and -alpha2b) in the Peg-IFN/RBV/simeprevir triple therapy
Safety,Efficacy
Others
The rate of sustained viral response (having undetectable serum HCV-RNA 24 weeks after the end of treatment)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Peg-IFN-alpha2a/RBV/simeprevir 12weeks plus Peg-IFN-alpha2a/RBV 36weeks: a total of 48 weeks treatment
Peg-IFN-alpha2a/RBV/simeprevir 12weeks plus Peg-IFN-alpha2a/RBV 36weeks: a total of 48 weeks treatment
Not applicable |
Not applicable |
Male and Female
Patients having genotype 1b high virus titer chronic hepatitis C (HCV-RNA more than 5 LogIU/mL) who did not achieve early viral response and failed in viral eradication with the previous Peg-IFN plus RBV treatment and who met the following inclusion criteria: laboratory data before study treatment of white blood cell count over 3,000/mm3, neutrophil count over 1,500/mm3,platelet count over 90,000/mm3, and hemoglobin over 12 g/dL
Patients who did not fulfill the criteria to receive the approved Peg-IFN-alpha/RBV/simeprevir treatment
80
1st name | |
Middle name | |
Last name | Shuhei Nishiguchi |
Hyogo College of Medicine
Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine
Mukogawa-cho 1-1, Nishinomiya, Hyogo
0798-45-6472
nishiguc@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Hirayuki Enomoto |
Hyogo College of Medicine
Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine
Mukogawa-cho 1-1, Nishinomiya, Hyogo
0798-45-6472
enomoto@hyo-med.ac.jp
Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine
None
Self funding
NO
2014 | Year | 04 | Month | 14 | Day |
Unpublished
Due to the development of DAAs, we could not recruit the scheduled number of patients and terminated the study before proceeding to the analysis.
Terminated
2013 | Year | 12 | Month | 05 | Day |
2013 | Year | 12 | Month | 16 | Day |
2014 | Year | 04 | Month | 14 | Day |
2018 | Year | 10 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016011
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