Open Label Clinical Study to Evaluate the Safety and Efficacy of ProvayBlueTM (Methylene Blue) for the Treatment of Acquired Methemoglobinemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoint: Number of Participants With and Without 50% Reduction in metHb Level
研究概览
简要总结
This is an open label, uncontrolled, Phase 4 study including 10 patients who present in hospital/urgent care setting with acquired methemoglobinemia. The population may include pediatric and adult patients (males and females of all ages are included).
The study will run in both the EU and the US. The aim of the study is to confirm safety and efficacy of ProvayBlueTM for the treatment of acquired methemoglobinemia and has been requested by the US-FDA as a Post-Marketing requirements.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric or adult patients (males and females of all ages are included) diagnosed with acquired methemoglobinemia and receiving treatment with ProvayBlue™ as per the treating physician's diagnosis and hospital standard of care.
- •Acquired methemoglobinemia is defined as a level of methemoglobinemia >30% or ≤30% in case of clinical symptoms (e.g. sleepiness, cyanosis, dizziness, etc.).
- •Written informed consent obtained prior to any data collection (retrospective and prospective) for this study and study specific assessments.
排除标准
- •Known severe hypersensitivity reactions to methylene blue or any other thiazine dye;
- •Known deficiency in glucose-6-phosphate dehydrogenase (G6PD) due to the risk of hemolytic anemia as well as lack of therapeutic effect;
- •Known deficiency in Nicotinamide Adenine Dinucleotide Phosphate Hydrogen (NADPH) reductase.
- •Known use of selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), MonoAmine Oxidase (MAO) inhibitors or drugs metabolised via CYP isoenzymes anticipated during the treatment phase of the study.
- •Women who refuse to stop breastfeeding for up to 8 days after receiving the last dose of ProvayBlueTM.
研究组 & 干预措施
ProvayBlue (Methylene Blue) arm
Methylene Blue 0.5% will be administered.
1 mg/kg will be administered intravenously over 5-30 minutes. If methemoglobin level remains above 30% or if clinical symptoms persist, give a repeat dose of up to 1 mg/kg one hour after the first dose.
干预措施: Methylene Blue (Drug)
结局指标
主要结局
Primary Efficacy Endpoint: Number of Participants With and Without 50% Reduction in metHb Level
时间窗: 1 hour
A 50% reduction in metHb level within 1 hour of the first dose of ProvayBlue for treatment of acquired methemoglobinemia. The timing of postdosing metHb level assays is inconsistent in clinical practice, for that reason metHb level at 1-hour postdosing was derived using linear interpolation.
次要结局
- Number of Participants With and Without Concomitant Normalization of Blood Pressure(2 hours)
- Number of Participants With Treatment-related Adverse Events(24 hours)
- Azure B Content in Blood Samples(24 hours)
- Second Dose(1 hour)
- Methylene Blue Content in Blood Samples(24 hours)
- Number of Participants With and Without Concomitant Normalization of Respiratory Rate(2 hours)
- Number of Participants With and Without Concomitant Normalization of Heart Rate(2 hours)