MEthylene Blue In Patients With Acquired Methemoglobinemia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-06

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acquired Methaemoglobinaemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ProvayBlue (Methylene Blue) arm

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.

Group Type EXPERIMENTAL

Methylene Blue

Intervention Type DRUG

Administration of Methylene Blue to treat acquired methaemoglobinaemia

Interventions

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Methylene Blue

Administration of Methylene Blue to treat acquired methaemoglobinaemia

Intervention Type DRUG

Other Intervention Names

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ProvayBlue

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No