Unique ID issued by UMIN | UMIN000010587 |
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Receipt number | R000012365 |
Scientific Title | Comprehensive and individualized trial of teraprevir/peginterferon alpha-2b/ribavirin for chronic hepatitis C patients with genotype 1 and high viral loads |
Date of disclosure of the study information | 2013/05/01 |
Last modified on | 2015/08/30 10:53:18 |
Comprehensive and individualized trial of teraprevir/peginterferon alpha-2b/ribavirin for chronic hepatitis C patients with genotype 1 and high viral loads
CITATION
Comprehensive and individualized trial of teraprevir/peginterferon alpha-2b/ribavirin for chronic hepatitis C patients with genotype 1 and high viral loads
CITATION
Japan |
chronic hepatitis C patients with genotype 1 and high viral loads
Hepato-biliary-pancreatic medicine |
Others
YES
To increase SVR ratio
Efficacy
virological response
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. patients with a positive HCV-RNA in the serum (more than or equal to 5.0 log IU/mL)
2. patients with genotype 1a or 1b
3. patients who gave consent in writing
1. chronic hepatitis such as autoimmune hepatitis and alcoholic hepatitis
2. pregnant women, women who may be expecting a child or lactating woman
3. women of child-bearing potential and their partner who cannot use birth control during administration and for 6 months after completion of administration
4. male partner for a pregnant woman, who cannot use birth control during administration and for 6 months after completion of administration
5. patients with past history of hypersensitivity to IFN or bovine-derived material
6. patients with past history of hypersensitivity to ribavirin and other nucleoside analog
7. patients with past history of hypersensitivity to biological products
such as vaccine
8. patients with uncontrolled diabetes mellitus
9. patients with uncontrolled heart disease
10. patients with hemoglobinopathy
11. chronic renal failure or severe renal dysfunction with less than 50 mL/min Ccr
12. patients with severe depression, suicidal thinking or suicide attempt or past history of any of these diseases
13. patients with severe liver dysfunction
14. patients with interstitial pneumonitis
15. patients with past history of drug hypersensitivity or tendency to develop allergy
16. patients receiving Shosaikoto
17. patients judged as inappropriate by the doctor
73
1st name | |
Middle name | |
Last name | Ken Sato |
Gunma University Graduate School of Medicine
Department of Medicine and Molecular Science
3-39-22
027-220-8127
satoken@gunma-u.ac.jp
1st name | |
Middle name | |
Last name | Ken Sato |
Gunma University Graduate School of Medicine
Department of Medicine and Molecular Science
Department of Medicine and Molecular Science
027-220-8127
satoken@gunma-u.ac.jp
Gunma University Graduate School of Medicine
Gunma University Graduate School of Medicine
Self funding
NO
2013 | Year | 05 | Month | 01 | Day |
Partially published
Completed
2011 | Year | 12 | Month | 01 | Day |
2012 | Year | 01 | Month | 01 | Day |
prospective cohort
2013 | Year | 04 | Month | 24 | Day |
2015 | Year | 08 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012365
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