MEthylene Blue In Patients With Acquired Methemoglobinemia (MEBIPAM)

Provepharm

Status and phase: Completed; Phase 4

Conditions: Acquired Methaemoglobinaemia

Treatments: Drug: Methylene Blue

Study type: Interventional

Funder types: Industry

Identifiers

NCT03395223

PVP-2016003

2017-000290-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

ProvayBlue (Methylene Blue) arm

Experimental group

Description:

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.

Treatment:

Drug: Methylene Blue