Chronic hepatitisC patients and compensated cirrhosis patients
Conditions
Sponsors
Saitama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)The following chronic hepatitis C patients were eligible to enter the trial 1) From 18 years old or over 2)Chronic hepatitis C 3)The presence of the liver biopsy is not asked 4) Genotype1a/1b first time treatment is HCV RNA>=5LogIU/mL 5)Genotype2a/2b retreatment 6)Platelet count >=90,000/micro L 7)WBC count>=3,000/micro L. Neutrophil count >=1,500/micro L. Hemoglobin concentration >=12g/dL. 8)Patients who provided written informed consents to participate the study prior to enrollment (2) The following hepatitis C and compensated cirrhosis patients were eligible to enter the trial 1) From 18 years old or over 2)hepatitis C and compensated cirrhosis 3)The presence of the liver biopsy is not asked 4)Platelet count >=75,000/micro L 5)WBC count>=3,000/micro L. Neutrophil count >=1,500/micro L. Hemoglobin concentration >=12g/dL. 6)The presence of the IFN treatment history is not asked 7)Patients who provided written informed consents to participate the study prior to enrollment
Exclusion criteria
Exclusion criteria: The following patients were excluded 1)Women of childbearing potential and pregnancy, lactating woman 2) allergic to ribavirin or nucleoside analogues 3)an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia) 4)hemoglobinopathy(thalassemia, sickle cell disease) 5) severe renal disease, Ccr <50ml/min 6) severe depression or psychosomatic disorders 7)severe liver disease 8) autoimmune hepatitis or HBV 9) drug allergy against interferon 10) Allergic to vaccine or biological preparations 11) Concomitant herbal medication of Sho-saikoto 12) history of interstitial pneumonia 13) high-dose lipid soluble vitamin agents using patients. 14)Other conditions considered inappropriate by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negative result of HCV RNA test at 24 weeks after terminating therapy. | — |
Countries
Japan
Contacts
Public ContactNobuaki Nakayama
Saitama Medical University Division of Gastroenterology and Hepatology,internal Medicine
Outcome results
None listed