Open label clinical study to evaluate the safety and efficacy of ProvayBlueTM (methylene blue injection USP) for the treatment of acquired methemoglobinemia

Provepharm SAS0 个研究点目标入组 10 人开始时间: 2017年10月30日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•1. Paediatric 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.).
•2. Written informed consent obtained prior to any data collection (retrospective and prospective) for this study and study specific assessments.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•1. Known severe hypersensitivity reactions to methylene blue or any other thiazine dye;
•2. Known deficiency in glucose-6-phosphate dehydrogenase (G6PD) due to the risk of hemolytic anemia as well as lack of therapeutic effect;
•3. Known deficiency in Nicotinamide Adenine Dinucleotide Phosphate Hydrogen (NADPH) reductase.
•4. Known use of selective serotonin reuptake inhibitors (SSRIs), serotonin and norephinephrine reuptake inhibitors (SNRIs), MonoAmine Oxidase (MAO) inhibitors or drugs metabolised via CYP isoenzymes anticipated during the treatment phase of the study.
•5. Women who refuse to stop breastfeeding for up to 8 days after receiving the last dose of ProvayBlue.

发起方