Unique ID issued by UMIN | UMIN000006283 |
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Receipt number | R000007437 |
Scientific Title | The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for hepatitis C virus-related compensated cirrhosis with osteoporosis |
Date of disclosure of the study information | 2016/12/31 |
Last modified on | 2014/09/05 15:12:09 |
The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for hepatitis C virus-related compensated cirrhosis with osteoporosis
CHALLENGE D trial
The beneficial effect and safety Eldecalcitol with combined peginterferon alpha-2a plus ribavirin for hepatitis C virus-related compensated cirrhosis with osteoporosis
CHALLENGE D trial
Japan |
Hepatitis C virus-related compensated cirrhosis with osteoporosis
Hepato-biliary-pancreatic medicine |
Others
NO
Examination of efficacy and safety of administration of Eldecalcitol with the Peginterferon alpha 2a/Ribavirin therapy to hepatitis C virus-related compensated cirrhosis patients with osteoporosis
Safety,Efficacy
Sustained Virological Response ( SVR )
ALT normalization
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Peginterferon alpha 2a
Ribavirin
Eldecalcitol
20 | years-old | <= |
Not applicable |
Male and Female
The following hepatitis C virus-related compensated cirrhosis patients were eligible to enter the trial
Osteoporosis
patients to whom it was confirmed that there was no hepatocellular carcinoma by imaging test (CT or MRI)
WBC counts>=3,000/microL
Neutrophil counts>=1,500/microL
Hemoglobin concentration>=12g/dL
Platelet counts>=75,000/microL
patients who provided written informed consent to participate the study prior to enrollment
The following patients were excluded
women of childbearing potential and pregnancy, lactating women
allergic to ribavirin or other nucleoside analoges
an uncontrollable heart trouble( myocardial infarction, heart failure, or arrhythmia)
hemoglobibopathy ( thalassemia, sickle cell disease)
severe renal disease or Ccr<50mL/min
severe depression or psychosomatic disorders
severe liver disease
autoimmune hepatitis or HBV
drug allegy against interferon
allergic to vaccine or biological preperations
concomitant herbal medication of Sho-saiko-to
history of interstitial pneumonia
patients who take active vitamin D3 other than Eldecalcitol
other conditions considerd
inappropriate by attending physician
50
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
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
06-6645-3811
kantansuinaika@med.osaka-cu.ac.jp
Department of Hepatology, Osaka City University
Osaka City University
Self funding
NO
2016 | Year | 12 | Month | 31 | Day |
Published
It is difficult to enroll the enough patients with cirrhosis from now on. We decide that the present study is closed.
Terminated
2011 | Year | 07 | Month | 20 | Day |
2014 | Year | 03 | Month | 31 | Day |
2014 | Year | 03 | Month | 31 | Day |
2011 | Year | 09 | Month | 05 | Day |
2014 | Year | 09 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007437
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