Status:
COMPLETED
MEthylene Blue In Patients With Acquired Methemoglobinemia
Lead Sponsor:
Provepharm SAS
Conditions:
Acquired Methaemoglobinaemia
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
This 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 pat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03395223
Start Date
July 6 2018
End Date
August 31 2020
Last Update
April 10 2023
Active Locations (1)
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1
Hôpital Lariboisière
Paris, France, 75475