An open-label randomized controlled trial to assess the efficacy and safety of chronic hepatitis C patients with vitaminD plus peginterferon alpha-2a /ribavirin.versus alfacalcidol plus peginterferon alpha-2a /ribavirin.
Not Applicable
- Conditions
- Chronic hepatitis C patients with genotype 1 and high viral load (>= 5 Log IU/mL)
- Registration Number
- JPRN-UMIN000004210
- Lead Sponsor
- Saitama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
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)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