NCT01759511终止2 期
A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Overall Safety Profile of Simtuzumab
研究概览
简要总结
The primary objective of this study is to evaluate the long term safety and tolerability of simtuzumab (GS-6624) in participants with idiopathic pulmonary fibrosis (IPF) who had previously participated in Gilead clinical trial AB0024-201.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Previous participation in Phase 1 Gilead clinical trial
- •Diagnosis of idiopathic pulmonary fibrosis
- •Females of childbearing potential and non-vasectomized males must agree to use highly effective methods of contraception
- •Females must discontinue nursing
- •Comply with study requirements
- •Have adequate organ function
排除标准
- •History or evidence of clinically significant disorder, condition or disease that would pose a risk or interfere with the study
- •Pregnant or lactating
- •Clinically significant heart, hepatic or renal disease
- •History of cancer within 5 years of screening
- •Infection that is not controlled despite antibiotics or other treatment
- •History of bleeding diathesis within the last 6 months of Day 1
- •Known history of human immunodeficiency virus, hepatitis B or C
- •Concern's for subjects compliance
- •Other conditions that might put the subject at high risk for treatment complications or reduce the chance to obtain data required
- •Placed on a lung transplant list
- •Previous participation in an idiopathic pulmonary fibrosis clinical trial other than for simtuzumab
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Simtuzumab
Experimental
Participants will receive simtuzumab.
干预措施: Simtuzumab (Drug)
结局指标
主要结局
Overall Safety Profile of Simtuzumab
时间窗: 30 days post last study treatment (up to 165 weeks)
The overall safety of simtuzumab was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade 3 or 4 AEs, AEs related to simtuzumab, and AEs leading to discontinuation of simtuzumab), treatment-emergent chemistry and hematology abnormality.
次要结局
- Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144(Weeks 72 and 144)
- Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144(Weeks 72 and 144)
- All-cause Mortality(Up to 165 weeks)
- Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120(Weeks 72 and 120)
研究者
研究点 (6)
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