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

Provepharm SAS0 个研究点目标入组 10 人开始时间: 2017年8月18日最近更新: 2018年5月28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 methylene blue as per the treating physician’s diagnosis and hospital standard of care.
•Acquired methemoglobinemia is defined as a level of methemoglobinemia >30% or =30% with associated 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 haemolytic anaemia as well as lack of therapeutic effect.

发起方