The beneficial effect of branched-chain amino acids with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients
- Conditions
- Chronic hepatitis type C
- Registration Number
- JPRN-UMIN000004252
- Lead Sponsor
- Department of Gastroenterology, Yamaguchi Univercity Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Not provided
1) Patient whose serum HCV RNA level under 5.0 log IU/ml and who taken initial therapy. 2) Patients with sensitivities for peg-interferon alpha 2b or other interferons. 3) Patients with sensitivities for vaccine. 4) Patients with sensitivities for ribavirin or other nucleic acid analogs. 5) a pregnant woman, or woman who may pregnant and who are nursing. 6) PAtients who had bad controled heart disease. 7) Patients who had hemoglobinemia. 8) Patients who had Chronic renal failure or whose creatinine clearance under 50ml/min. 9) Patients who had depression. 10) Patients who had severe liver disfunction or bile duct obstruction. 11) Patients who had cerebral hemorrhage or cerebral infarction. 12) PAtients who medicated by shousaikoto. 13) Patients who had autoimmune hepatitis. 14) Patients who had chronic hepatitis type B, alcoholic liver injury. 15) Patients who were disqualified by doctor in attendance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of nagative HCV RNA at 24 weeks after the initiation of treatment (The SVR rate)
- Secondary Outcome Measures
Name Time Method 1) Rate of negative HCV RNA (at 4 weeks, 12 weeks of combination therapy and end of the initiation therapy) 2) Change in hemoglobin 3) Dose of drug (peginterferon dose, ribavirin dose) 4) Change in insulin resistance 5) Occurrence of side effect