Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for non-responder/relapser to pegylated interferon or non pegylated interferon plus ribaviri
- Conditions
- Chronic hepatitis C
- Registration Number
- JPRN-UMIN000003709
- Lead Sponsor
- Chugai pharmaceutical CO., LTD.
- Brief Summary
The SVR rate was higher in the patients receiving 48 weeks of treatment (long-term treatment patients) in the 516-patient serotype 1 group of the effectiveness analysis set. The SVR rate was similar in the patients receiving 48 weeks of treatment (long-term treatment patients) and the patients receiving 48 weeks of treatment in the 206-patient serotype 2 group of the effectiveness analysis set.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 851
Not provided
1. Despite of administering adequate doses of PEG IFN plus RBV for 48weeks, HCV RNA did not become negative by 36weeks 2. Patients who have had treatment of PEG IFN plus RBV for 72weeks 3. Coadministration of Shosaikoto 4. History of interstitial pneumonia 5. Autoimmune hepatitis 6. Hypersensitivity to PEG IFN or RBV or to any of the excipients or biological products or nucleotide analogs 7. Low birth weight baby, neonate, infant or children under age 3 8. Pregnancy, uncertainty pregnancy or brest feeding women 9. Uncontrolled cardiac disease 10. Hemoblobinopathies (e.g. thalassemia, sickle cell anemia) 11. Chronic renal failure or CCl<50mL/min of renal dysfunction 12. Histry or presence of severe depression, severe neuropsychiatric disorder with suicidal ideation or suicide attempt 13.Severe hepatic dysfunction
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained virological response (SVR) rate and confirmation of the safety profile including greater than 48wks treatment period
- Secondary Outcome Measures
Name Time Method