Pirfenidone for Progressive Fibrotic Sarcoidosis
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time until clinical worsening (TCW)
研究概览
简要总结
Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis
详细描述
Patients who meet the inclusion and exclusion criteria will be randomized to be treated with either placebo or pirfenidone at the current approved dosage for idiopathic pulmonary fibrosis at a 2:1 pirfenidone to placebo ratio. Patients treated with pirfenidone will be titrated using the following schedule:
One 267 mg capsules three times a day for two weeks. Two 267 mg capsules three times a day for two weeks Three 267 mg capsules three times a day thereafter Patients will be instructed to take all doses of medication with food. Dosage will be titrated on an individual basis depending on patient tolerance of medication.
Those randomized to placebo will receive the same schedule using placebo tablets.
Block randomization will be done at each site. Liver function tests will be evaluated as listed above. If the patient has an abnormal liver function test, then the dose will be adjusted per the company's protocol for commercial drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Placebo controlled
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of sarcoidosis
- •Pulmonary function testing with a Composite Physiologic Index (CPI) score of greater than 40
- •Patient must have evidence of >20% fibrosis on high resolution cat scan
- •Patients must be on a stable prednisone therapy for sarcoidosis for at least two months and no change in other immunosuppressives in the two months prior to entry into study
- •Age greater than 18 and less than
- •Able to provide written informed consent for participation in the study
排除标准
- •Patients receiving therapy for precapillary pulmonary hypertension.
- •Patients with liver disease Childs class 3 or 4
- •Patients with a left ventricular ejection fraction of less than 40%
- •Patients receiving more than 20 mg prednisone daily or its equivalent
- •Patients with massive hemoptysis within prior three months. Patients with mycetomas are eligible as long as no massive hemoptysis in prior three months.
- •Patients with clinically important co-existing disease which in the opinion of the investigator is likely to affect patient's chance for survival during the course of the study
- •Patient who is pregnant, lactating, intending to become pregnant during the study, or child bearing capacity who is not willing to use appropriate birth control methods approved by investigator
研究组 & 干预措施
Pirfenidone
Pirfenidone titrated to three 267 mg tablets three times a day
干预措施: Pirfenidone (Drug)
Placebos
Placebo titrated to three tablets three times a day
干预措施: Placebos (Drug)
结局指标
主要结局
Time until clinical worsening (TCW)
时间窗: two years
TCW
次要结局
- Change in forced vital capacity (FVC)(two years)
- Change in CPI(two years)
研究者
Robert P Baughman
Professor
University of Cincinnati