JPRN-UMIN000006265已完成未知
Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC - Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 487
研究概览
简要总结
The safety analysis set included 487 of the 494 patients for whom case report forms were collected. This excluded 7 patients who were excluded from the safety analysis. The efficacy analysis set included 392 of the 487 patients in the safety analysis set. This excluded 95 patients who were excluded from the efficacy analysis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •All contraindications specified in the Japanese package insert of PEGASYS/COPEGUS must be adhered. The major exclusion criteria are: #Coadministration of Shosaikoto #Autoimmune hepatitis #Severe hepatic dysfunction #Unstable or uncontrolled cardiac disease #Hypersensitivity to peginterferon or ribavirin or to any of the excipients #Pregnancy (A pregnancy needs to be reliably ruled out before treatment initiation and reliably prevented during treatment, please see the Japanese package insert for PEGASYS/COPEGUS for further details) #Breast-feeding women #Hemoglobinopathies (e.g. thalassemia, sickle-cell anemia)
研究者
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