Clinical trial NCT03395223: MEthylene Blue In Patients With Acquired Methemoglobinemia
Official title: Open Label Clinical Study to Evaluate the Safety and Efficacy of ProvayBlueTM (Methylene Blue) for the Treatment of Acquired Methemoglobinemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acquired Methaemoglobinaemia
Keywords: Acquired Methaemoglobinemia
Methylene Blue
Lead sponsor: Provepharm SAS
Sponsor class: INDUSTRY
First posted: 2018-01-10
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Efficacy Endpoint: Number of Participants With and Without 50% Reduction in metHb Level
timeFrame: 1 hour
Secondary outcomes:
measure: Number of Participants With and Without Concomitant Normalization of Respiratory Rate
timeFrame: 2 hours
measure: Number of Participants With and Without Concomitant Normalization of Heart Rate
timeFrame: 2 hours
measure: Number of Participants With and Without Concomitant Normalization of Blood Pressure
timeFrame: 2 hours
measure: Second Dose
timeFrame: 1 hour
measure: Number of Participants With Treatment-related Adverse Events
timeFrame: 24 hours
measure: Methylene Blue Content in Blood Samples
timeFrame: 24 hours
measure: Azure B Content in Blood Samples
timeFrame: 24 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière
Study officials:
affiliation: Hôpital Lariboisière
name: Bruno Megarbane
role: PRINCIPAL_INVESTIGATOR
References: