An open-label randomized controlled trial to assess the efficacy and safety of chronic hepatitis C and compensated cirrhosis patients with the prescribing pattern of vitaminD plus peginterferon alpha-2a /ribavirin.
- Conditions
- Chronic hepatitisC patients and compensated cirrhosis patients
- Registration Number
- JPRN-UMIN000008342
- Lead Sponsor
- Saitama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method egative result of HCV RNA test at 24 weeks after terminating therapy.
- Secondary Outcome Measures
Name Time Method