Double-Blind, Placebo-Controlled Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change from baseline at 30 minutes in DLCO after administration of a single dose of TSC versus placebo in patients with ILD
研究概览
简要总结
This is a randomized, placebo-controlled study of Trans Sodium Crocetinate (TSC) in patients with Interstitial Lung Disease (ILD), age 30-85 (inclusive). The primary objective of the study is to determine the effect of TSC on lung function as measured by diffusing capacity of the lungs for carbon monoxide (DLCO) in patients with ILD; the secondary objectives are to determine the effect of TSC on the 6-minute walk test (6MWT), heart rate recovery (HRR), and Borg Scale in patients with ILD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, age 30 to 85 years at screening
- •Able to provide informed consent and agree to adhere to all study visits and requirements
- •Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug
- •Established diagnosis of ILD (clinical, radiographic, or histologic)
- •SpO2 ≥ 88% at rest by pulse oximetry while breathing ambient air
- •Free of any active cardiovascular or neuromuscular disease, at PI discretion
- •Clinically stable disease with no major medication changes in the last 4 weeks
- •Forced vital capacity (FVC) ≥ 45% of predicted (within past 6 months)
- •DLCO corrected for hemoglobin 30-90% of predicted, inclusive (within past 6 months)
- •Sars-CoV-2 negative at screening
排除标准
- •Known allergy to study medication
- •Pregnancy or lactation
- •Current smoker
- •Inability to perform pulmonary function testing
- •Active infection at screening or day of study visit
- •Known pulmonary hypertension (PH) requiring PH-specific treatment
- •AST/ALT ≥ 3x ULN and/or total bilirubin ≥ 2x ULN
- •Received any investigational medicine (IMP) within past 30 days
- •Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant.
- •Current alcohol or substance abuse
- •Known active or latent hepatitis B or C
- •History of end-stage liver or renal disease
- •Positive COVID test anytime within 3 months of screening. Note:
- •Patients who were previously vaccinated for COVID are allowed
- •History of venous thromboembolic disease
- •History of acute or chronic ophthalmologic conditions currently requiring treatment
研究组 & 干预措施
2.5 mg/kg Trans Sodium Crocetinate
Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC.
干预措施: Trans Sodium Crocetinate (Drug)
Placebo
Subjects will receive a single IV bolus dose of 7 mL Normal Saline.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline at 30 minutes in DLCO after administration of a single dose of TSC versus placebo in patients with ILD
时间窗: 30 minutes
Compare the proportion of patients who achieve a prespecified level of improvement in DLCO 30 minutes after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms.
次要结局
- Change from baseline in the Borg Scale after the 6MWT(60 minutes)
- Change from baseline in 6MWT after administration of a single dose of TSC versus placebo in patients with ILD(60 minutes)
- Change from baseline in HRR after each 6MWT(60 minutes)