MEthylene Blue In Patients With Acquired Methemoglobinemia

Provepharm SAS7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acquired Methaemoglobinaemia

Interventions

Methylene BlueDRUG

Administration of Methylene Blue to treat acquired methaemoglobinaemia

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Hôpital Lariboisière

Paris, France

Outcomes

Primary Outcomes

Primary Efficacy Endpoint: Number of Participants With and Without 50% Reduction in metHb Level

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.

Time frame: 1 hour

Secondary Outcomes

Number of Participants With and Without Concomitant Normalization of Respiratory Rate

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.

Time frame: 2 hours

Number of Participants With and Without Concomitant Normalization of Heart Rate

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.

Time frame: 2 hours

Number of Participants With and Without Concomitant Normalization of Blood Pressure

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.

Time frame: 2 hours

Second Dose

Evaluation of the patients who achieve a 50% reduction in metHb level after a second dose of ProvayBlue

Time frame: 1 hour

Number of Participants With Treatment-related Adverse Events

Number of participants who experience a treatment emergent adverse event assessed by the investigator as being related to study drug..

Data from ClinicalTrials.gov

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