Peginterferon-alpha plus ribavirin therapy following twice-daily administration of interferon-beta in patients with genotype 1 and high viral load.
- Conditions
- patients with HCV genotype 1 and high viral load
- Registration Number
- JPRN-UMIN000003410
- 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
- 35
Not provided
Patients with autoimmune hepatitis. Pregnant woman, woman of child-bearing potential, or breast-feeding woman. Patients and thier partners who cannot use birth control durinf therapy and for 6 months after end of administration. Patients with hypersensitivity to ribavirin, or other nucleoside analogs. Patients with uncontrollable heart failure. Patients with hemoglobinopathy. Patinets with chronic renal failure and compromised renal function (equal to or less than 50mL/min of creatinine clearance. Patients with severe depression or psychiatric disease including suicide attempt or with history of suicide attempt. Patients with severe liver dysfunction. Patients with hypersensitivity to biological drug such as vaccine. Patients with hypersensitivity to interferon and bovine-derived material. Patients with interstitial pneumonia. Patients with a history of drug sensitivity or with allergic tendency. Patients administrated with Syousaikotou. Patients with being disqualified by the doctor. Patients who received peginterferon plus ribavirin therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Sustained virological response (SVR) rate
- Secondary Outcome Measures
Name Time Method The rate of loss of serum HCV-RNA levels and viral dynamics during therapy The incidence ratio of adverse effect