NCT01779518Approved For Marketing不适用
An Expanded Access Phase 2 Study of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon for 24 Weeks in Subjects Who Have Undergone Liver Transplantation and Who Have Aggressive, Recurrent Hepatitis C Infection
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
研究概览
简要总结
This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > or = 18 years
- •Previously undergone orthotopic liver transplant (OLT) at least 2 months prior to the planned start of dosing
- •Aggressive Hepatitis C infection (including fibrosing cholestatic hepatitis C)
- •Life expectancy of < 12 months if the HCV is left untreated
排除标准
- •History of clinically significant drug allergy to nucleoside/nucleotide analogs
- •Participation in a clinical study with an investigational drug or biologic within 1 month prior to anticipated dose administration, unless information is available to determine that there is no safety or drug-drug interaction risk to the subject
- •Unable or unwilling to follow the contraception requirements
研究者
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