Title
MEthylene Blue In Patients With Acquired Methemoglobinemia
Open Label Clinical Study to Evaluate the Safety and Efficacy of ProvayBlueTM (Methylene Blue) for the Treatment of Acquired Methemoglobinemia
Phase
Phase 4Lead Sponsor
Provepharm SasStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Acquired MethaemoglobinaemiaIntervention/Treatment
Methylene BlueStudy Participants
7This 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.
Administration of Methylene Blue to treat acquired methaemoglobinaemia
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.
Inclusion Criteria: 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. Exclusion Criteria: 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.
| Event Type | Organ System | Event Term | ProvayBlue (Methylene Blue) Arm |
|---|
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.
Normalization of the respiratory rate within 2 hours of the first dose of ProvayBlue. The normal range used for respiratory rate was 12-20 breaths per minute.
Normalization of the heart rate within 2 hours of the first dose of ProvayBlue. The normal range used for heart rate was 50-100 beats per minute.
Normalization of blood pressure standard values within 2 hours of the first dose of ProvayBlue. The normal range used for systolic blood pressure was was 90-140 mm HG and the normal range used for diastolic blood pressure was 60-90 mm HG.
Evaluation of the patients who achieve a 50% reduction in metHb level after a second dose of ProvayBlue
Number of participants who experience a treatment emergent adverse event assessed by the investigator as being related to study drug..
Blood samples will be analyzed for methylene blue content
Blood samples will be analyzed for Azure B content
