Clinical study to find out whether methylene blue injection is safe and effective in the treatment of a blood disorder (methemoglobinemia) resulting from exposure to toxic agents (drugs or environmental poisons)
- Conditions
- Acquired methemoglobinemiaMedDRA version: 20.0Level: LLTClassification code 10054290Term: Acquired methemoglobinemiaSystem Organ Class: 100000012871Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2017-000290-37-FR
- Lead Sponsor
- Provepharm SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To confirm that methylene blue after a single administration is efficacious in patients with acquired methemoglobinemia.;Secondary Objective: To evaluate the efficacy of a single dose of 1 mg/kg of methylene blue<br>· To evaluate the efficacy of a second dose of 1 mg/kg of methylene blue to further reduce metHb levels when metHb is not fully reduced by a single dose;<br>· To evaluate the normalisation of the respiratory rate, heart rate and blood pressure of patients who achieve a reduction in metHb level within 2 hours of receiving the first dose of methylene blue<br>· To confirm the safety and tolerability of methylene blue injection in patients with acquired methemoglobinemia.;Primary end point(s): A 50% reduction in metHb level for treatment of acquired methemoglobinemia.;Timepoint(s) of evaluation of this end point: within 1 hour of the first dose of ProvayBlue
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Concomitant normalisation of the respiratory rate, heart rate and blood pressure <br>2) Evaluation of the patients who achieve a 50% reduction in metHb level after a single<br>dose of methylene blue in addition to normalisation of the respiratory rate, heart rate and blood pressure;<br>3a) Evaluation of the number of patients who achieve a 50% reduction in metHb level in addition to 3b) normalisation of the respiratory rate, heart rate and blood pressure· <br>4) Evaluation of the patients who achieve a 50% reduction in metHb level after a second dose of methylene blue, in addition to normalisation of the respiratory rate, heart rate and blood pressure, in cases where a single dose did not completely normalise metHb level;;Timepoint(s) of evaluation of this end point: for 1), within 2 hours of the first dose of methylene blue;<br>for 3a) within one hour after treatment with methylene blue<br>for 3b) within 2 hours of receiving the first dose of methylene blue