Comprehensive and individualized trial of teraprevir/peginterferon alpha-2b/ribavirin for chronic hepatitis C patients with genotype 1 and high viral loads
- Conditions
- chronic hepatitis C patients with genotype 1 and high viral loads
- Registration Number
- JPRN-UMIN000010587
- Lead Sponsor
- Gunma University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 73
Not provided
1. chronic hepatitis such as autoimmune hepatitis and alcoholic hepatitis 2. pregnant women, women who may be expecting a child or lactating woman 3. women of child-bearing potential and their partner who cannot use birth control during administration and for 6 months after completion of administration 4. male partner for a pregnant woman, who cannot use birth control during administration and for 6 months after completion of administration 5. patients with past history of hypersensitivity to IFN or bovine-derived material 6. patients with past history of hypersensitivity to ribavirin and other nucleoside analog 7. patients with past history of hypersensitivity to biological products such as vaccine 8. patients with uncontrolled diabetes mellitus 9. patients with uncontrolled heart disease 10. patients with hemoglobinopathy 11. chronic renal failure or severe renal dysfunction with less than 50 mL/min Ccr 12. patients with severe depression, suicidal thinking or suicide attempt or past history of any of these diseases 13. patients with severe liver dysfunction 14. patients with interstitial pneumonitis 15. patients with past history of drug hypersensitivity or tendency to develop allergy 16. patients receiving Shosaikoto 17. patients judged as inappropriate by the doctor
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method virological response
- Secondary Outcome Measures
Name Time Method