Acquired methemoglobinemia MedDRA version: 20.0 Level: LLT Classification code 10054290 Term: Acquired methemoglobinemia System Organ Class: 100000004851
Conditions
Sponsors
Provepharm SAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 · 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; · 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 · 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Concomitant normalisation of the respiratory rate, heart rate and blood pressure 2) Evaluation of the patients who achieve a 50% reduction in metHb level after a single dose of methylene blue in addition to normalisation of the respiratory rate, heart rate and blood pressure; 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· 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; for 3a) within one hour after treatment with methylene blue for 3b) within 2 hours of receiving the first dose of methylene blue | — |
Countries
France, Germany, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
Provepharm SAS
Outcome results
None listed