Randomized controlled trial of 72-week Peg-IFN alpha-2b/ribavirin therapy with or without EPL (polyenephosphatidylcholine) for chronic hepatitis C patients with genotype 1b and high viral load
Phase 4
- Conditions
- Chronic hepatitis C with serotype 1 and high viral load
- Registration Number
- JPRN-UMIN000000646
- Lead Sponsor
- Gunma Liver Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1.The complication of the other liver diseases 2.Liver cirrhosis 3.Prick test-positive 4.IFN,rivavirin or EPL sensitivity 5.During pregnancy, the possibility of pregnancy or during lactation 6.Depression 7.The possibility of autoimmune diseases 8.Uncontrolled diabetes 9.Uncontrolled hypertension 10.While taking Sho-saiko-to 11.Febrile condition 12.Hematopenia 13.Poor function of bone marrow, kidney, heart or lung
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.The improvement of sustained viral response 2.The frequency of dose reduction of ribavirin due to anemia
- Secondary Outcome Measures
Name Time Method