NCT00189176已完成1 期
Phase I/II Trial of Tetrathiomolybdate (TM) in Patients With Usual Interstitial Pneumonia Refractory to Previous Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
This study will evaluate the safety of the administration of a copper chelating agent, tetrathiomolybdate, for patients with idiopathic pulmonary fibrosis that have failed previous treatment. The primary endpoint for this study is safety with secondary endpoints including change in pulmonary function, exercise capacity, and quality of life.
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
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic pulmonary fibrosis
- •Disease progression despite six months of treatment (steroids with/without azathioprine or cyclophosphamide) defined by at least one of the following:
- •Increased symptoms
- •Decline in forced vital capacity of at least 10%
- •Decline in diffusion capacity for carbon monoxide of at least 20%
- •Increased infiltrate on CXR or high resolution CT scan
- •Taking < 15 mg prednisone for at least 30 days prior to screening
- •Age 35-80, inclusive
- •Able to understand a written informed consent and comply with the study protocol
排除标准
- •Significant environmental exposure
- •Diagnosis of collagen vascular disease
- •Evidence of active infection
- •Clinically significant cardiac disease:
- •Myocardial infarction, coronary artery bypass or angioplasty within 6mo
- •Unstable angina pectoris
- •Congestive heart failure requiring hospitalization within 6 months
- •Uncontrolled arrhythmia
- •Poorly controlled or severe diabetes mellitus
- •Pregnancy or lactation
- •Women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm, Norplant)
- •Current enrollment in another experimental protocol
- •Physiologic Criteria:
- •FEV1/FVC < 0.60
- •Laboratory Criteria:
- •Total bilirubin > 1.5 X upper limit normal
- •AST or ALT > 3X upper limit normal
- •Alkaline phosphatase > 3X upper limit normal
- •White blood cell count < 2,500/mm3
- •Hematocrit < 30%
- •Platelets < 100,000/mm3
- •Prothrombin time INR > 1.5
研究组 & 干预措施
Tetrathiomolybdate
Experimental
干预措施: Tetrathiomolybdate (Drug)
结局指标
主要结局
Safety
时间窗: 1 year
次要结局
未报告次要终点
研究者
Kevin R. Flaherty
Associate Professor of Medicine
University of Michigan
研究点 (1)
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