An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- All adverse events up to the end of study
研究概览
简要总结
Open-label therapy will be administered to up to 220 patients, following completion of either InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term safety of subcutaneous Interferon gamma-1b. The study duration will be 5 years.
详细描述
Open-label therapy will be administered subcutaneously. Patients enrolled will continue to receive Interferon gamma-1b therapy three times per week and will be evaluated at 6-week intervals. Patients not taking Interferon gamma-1b at enrollment will re-initiate therapy with subcutaneous Interferon gamma-1b under a dose-escalation scheme, reaching full dose after 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment in Protocol GIPF 002 Part B or GIPF-004
- •Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study Completion Visit in GIPF-004
- •Able to understand and sign a written informed consent form and comply with the requirements of the study
排除标准
- •pregnancy or lactation
- •lack of adherence to either GIPF-002 or GIPF-004 study protocols and treatment regimens
- •if Principal Investigator deems patient is unsuitable for study
结局指标
主要结局
All adverse events up to the end of study
时间窗: 3.5 years
Survival status at end of study
时间窗: 3.5 years
Serum antibodies to Interferon gamma-1b after the last injection.
时间窗: 3.5 years
次要结局
未报告次要终点