Unique ID issued by UMIN | UMIN000013017 |
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Receipt number | R000015196 |
Scientific Title | Efficacy and safety of simeprevir/pegylated-interferon/ribavirin combination therapy with Vitamin D3 in chronic hepatitis C patients: multi-center, open label, randomized, controlled study |
Date of disclosure of the study information | 2014/01/30 |
Last modified on | 2016/07/28 16:22:49 |
Efficacy and safety of simeprevir/pegylated-interferon/ribavirin combination therapy with Vitamin D3 in chronic hepatitis C patients: multi-center, open label, randomized, controlled study
Simeprevir/peg-interferon/ribavirin combination therapy with or without Vitamin D3
Efficacy and safety of simeprevir/pegylated-interferon/ribavirin combination therapy with Vitamin D3 in chronic hepatitis C patients: multi-center, open label, randomized, controlled study
Simeprevir/peg-interferon/ribavirin combination therapy with or without Vitamin D3
Japan |
Chronic hepatitis C
Hepato-biliary-pancreatic medicine |
Others
YES
To confirm the efficacy and safety of simeprevir/peg-interferon/ribavirin combination therapy with Vitamin D3 in chronic hepatitis C patients with IL28B minor genotype.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Sustained virological response rate
Safety and HCV-RNA dynamics
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
Central registration
2
Treatment
Medicine | Food |
Simeprevir/pegylated-interferon/ribavirin combination therapy with Vitamin D3 for 24weeks
Simeprevir/pegylated-interferon/ribavirin combination therapy without Vitamin D3 for 24weeks
18 | years-old | <= |
85 | years-old | > |
Male and Female
Patient with HCV RNA high viral load (>5.0 log IU/mL) as determined by quantitative analysis with real-time polymerase chain reaction (PCR), infection with HCV genotype 1b, IL28B (rs8099917) minor genotype (TG or GG), white blood cell (WBC) count > 2,000/mm3, neutrophil count > 1,500/mm3, platelet count > 80,000/mm3, and hemoglobin concentration > 11.0 g/dl.
1. other liver diseases, including autoimmune hepatitis, primary biliary cirrhosis, and alcoholic disease
2. positive result for hepatitis B surface antigen and antibody to human immunodeficiency virus type-1
3. decompensated liver cirrhosis
4. severe renal disorder
5. pregnant woman or lactating mother
6. allergy to IFN, ribavirin, protease inhibitor or biological preparations such as vaccines.
7. poorly controlled diabetes; poorly controlled heart failure;poorly controlled hypertension
8. medication with Chinese herbal medicine
9. medical history of interstitial pneumonia
10. severe depression
11. hyperparathyroidism
12. hypercarcemia
13. medication with other vitamin D preparations
150
1st name | |
Middle name | |
Last name | Masanori Atsukawa |
Nippon Medical School Chiba Hokusoh Hospital
Division of Gastroenterology
1715 Kamakari, Inzai, Chiba, 270-1694, Japan
0476-99-1111
atsukawa-nms@umin.ac.jp
1st name | |
Middle name | |
Last name | Masanori Atsukawa |
Nippon Medical School Chiba Hokusoh Hospital
Division of Gastroenterology
1715 Kamakari, Inzai, Chiba, 270-1694, Japan
0476-99-1111
atsukawa-nms@umin.ac.jp
Nippon Medical School Chiba Hokusoh Hospital
None
Self funding
None
NO
2014 | Year | 01 | Month | 30 | Day |
Published
Completed
2013 | Year | 12 | Month | 09 | Day |
2013 | Year | 12 | Month | 09 | Day |
2014 | Year | 01 | Month | 30 | Day |
2016 | Year | 07 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015196
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Research case data | |
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