JPRN-UMIN000003709已完成4 期
Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for non-responder/relapser to pegylated interferon or non pegylated interferon plus ribavirin - PEGASYS/COPEGUS Re-treatment
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 851
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •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
研究者
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