Unique ID issued by UMIN | UMIN000004141 |
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Receipt number | R000004781 |
Scientific Title | Darbepoetin alpha for anemia in patients with chronic hepatitis C treated with combination therapy of peginterferon alpha-2b plus ribavirin |
Date of disclosure of the study information | 2010/09/01 |
Last modified on | 2023/03/12 11:56:13 |
Darbepoetin alpha for anemia in patients with chronic hepatitis C treated with combination therapy of peginterferon alpha-2b plus ribavirin
Darbepoetin for ribavirin-induced anemia in chronic hepatitis C patients
Darbepoetin alpha for anemia in patients with chronic hepatitis C treated with combination therapy of peginterferon alpha-2b plus ribavirin
Darbepoetin for ribavirin-induced anemia in chronic hepatitis C patients
Japan |
Chronic hepatitis C
Hepato-biliary-pancreatic medicine |
Others
NO
To assess by a randomized, controlled trial the efficacy and safety of darbepoetin alpha for anemia in aged women with chronic hepatitis C treated with combination therapy of peginterferon alpha-2b plus ribavirin.
Safety,Efficacy
The incidence rates of negative result of qualitative HCV RNA test at 12 weeks of treatment, end of treatment, and 24 weeks after terminating therapy.
1) The incidence rates of dose reduction and discontinuation of ribavirin.
2) Changes in hemoglobin concentration.
3) The incidence rates of completion of the combination therapy of peginterferon alpha-2b plus ribavirin.
4) Assessment of the QOL by SF-36 ver. 2 at baseline and at 4 and 24 weeks of treatment.
5) Adverse events and their incidence rates and grade.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Darbepoetin alpha in combination with peginterferon alpha-2b plus ribavirin.
Peginterferon alpha-2b plus ribavirin.
50 | years-old | <= |
70 | years-old | > |
Female
1. Chronic hepatitis C with HCV genotype 1 and high viral load (HCV RNA >= 5 Log IU/mL).
2. 50 years-old or older and youger than 70 years-old.
3. Women.
4. Hemoglobin concentration >= 12 g/dL and < 15 g/dL.
5. White blood cell count >=4,000/mm3.
6. Neutrophil count >=1,500/mm3.
7. Platelet count >=10,000/mm3.
1. Allergic to peginterferon alpha-2b or other interferon preparations.
2. Allergic to vaccine or biological preparations.
3. Allergic to ribavirin or other nucleoside analogue preparations.
4. Pregnant or under breast feeding.
5. Uncontrolled cardiovascular diseases.
6. Abnormal hemoglobinemia.
7. Chronic renal failure or creatinine clearance value less than 50 mL/min.
8. Severe depression or psychiatric disorders including a history of a suicide attempt.
9. Severe or decompensated liver disease.
10. Vascular diseases of central nervous system.
11. Autoimmune liver diseases.
12. Concomitant herbal medication such as Sho-saiko-to.
13. Allergic to darbepoetin alpha or other erythropoietin preparations.
14. Other conditions considered inappropriate by attending physician.
30
1st name | Fusao |
Middle name | |
Last name | Ikeda |
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Department of Molecular Hepatology
700-8558
2-5-1, Shikata-cho, Kita-ku, Okayama 700-8558, Japan
086-235-7219
fikeda@md.okayama-u.ac.jp
1st name | Yoshiaki |
Middle name | |
Last name | Iwasaki |
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Department of Gastroenterology and Hepatology
700-8558
2-5-1, Shikata-cho, Kita-ku, Okayama 700-8558, Japan
086-235-7219
yiwasaki@cc.okayama-u.ac.jp
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
None
Self funding
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
2-5-1, Shikata-cho, Kita-ku, Okayama 700-8558, Japan
086-235-6762
mae6605@adm.okayama-u.ac.jp
NO
2010 | Year | 09 | Month | 01 | Day |
Unpublished
21
No longer recruiting
2010 | Year | 07 | Month | 27 | Day |
2010 | Year | 07 | Month | 27 | Day |
2010 | Year | 09 | Month | 01 | Day |
2024 | Year | 03 | Month | 31 | Day |
2010 | Year | 09 | Month | 01 | Day |
2023 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004781
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