A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 23
- 主要终点
- Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28
研究概览
简要总结
The purpose of this study is to assess the efficacy of IV gallium to improve pulmonary function as measured by a 5% or greater relative improvement in forced expiratory volume in one second (FEV1) from baseline to Day 28.
Funding Source - FDA OOPD
详细描述
This is a phase 2, multi-center, randomized, placebo-controlled trial in adults with CF chronically infected with P. aeruginosa. The study will evaluate the safety and clinical efficacy of a five day infusion of IV gallium nitrate (IV gallium). The purpose of this study is to assess the efficacy of IV gallium to improve pulmonary function as measured by a 5% or greater relative improvement in forced expiratory volume in one second (FEV1) from baseline to Day 28.
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, Investigator, Outcomes Assessor)
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
- •Greater than or equal to 18 years of age at Screening
- •Documented chronic colonization with P. aeruginosa defined as dentification in two sputum or oropharyngeal cultures within the year prior to Day 1
- •Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
- •sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
- •two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
- •Abnormal nasal potential difference (NPD; change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)
- •FEV1 ≥ 25 % of predicted value at Screening
- •Able to expectorate sputum
- •Serum liver function tests ≤ 2.5 x upper limit of normal at Screening
- •Serum urea nitrogen (BUN) ≤ 1.5 x upper limit of normal at Screening
- •Serum creatinine ≤ 2.0 mg/dl and ≤ 1.5 x upper limit of normal at Screening
- •Hemoglobin ≥ 9 g/dl, platelets ≥ 100,000/mm3, and white blood cells (WBC)
- •≥ 4,500/mm3 at Screening
- •Ionized calcium ≥ lower limit of normal at Screening
- •Written informed consent obtained from subject or subject's legal representative
- •Able to communicate with the Investigator and comply with the requirements of the protocol
- •If female and of childbearing potential, must have a negative pregnancy test on Day 1 prior to receiving study drug
- •If female and of childbearing potential, is willing to use adequate contraception for the duration of the study through Visit 5, as determined by the investigator
- •If male and able to father a child, is willing to use adequate contraception for the duration of the study through Visit 5, as determined by the investigator
- •Clinically stable with no significant changes in health status within 14 days prior to Day 1
- •Exclusion criteria:
- •Use of inhaled antibiotics within seven days prior to Day 1
- •Unable or unwilling to withhold use of chronic inhaled antibiotics through Day 28
- •Use of intravenous, inhaled, or oral antibiotics for an acute indication within 14 days prior to Day 1
- •Use of bisphosphonates within seven days prior to Day 1
- •History of osteoporosis (defined as the most recent dexa scan with a T-score ≤ -2.5 with the dexa scan performed within the five years prior to Screening)
- •Lactating female
- •Known sensitivity to gallium
排除标准
- 未提供
研究组 & 干预措施
5 day of infusion of gallium nitrate
Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days.
干预措施: Gallium nitrate (Drug)
5 day of infusion of normal saline
Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga
干预措施: Normal Saline (Drug)
结局指标
主要结局
Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28
时间窗: Baseline to Day 28
Difference between treatment groups in the proportion of subjects with 5% or greater relative change in FEV1 (liters) from baseline to Day 28.
次要结局
- Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 to Day 56)
- Relative Change in FEV1 (Liters) From Baseline to Day 56(Day 1 to Day 56)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 to Day 56)
- Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), From Baseline to Day 56(Day 1 to Day 56)
- Absolute Change in P. Aeruginosa Sputum Density (log10 (CFU)) From Baseline to Day 56(Day 1 to Day 56)
研究者
Chris Goss
Professor, Medicine/Pulmonary & Critical Care Medicine
University of Washington