MEthylene Blue In Patients With Acquired Methemoglobinemia
Status:
Completed
Trial end date:
2020-08-31
Target enrollment:
Participant gender:
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 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.