Phase 4
N=7
MEthylene Blue In Patients With Acquired Methemoglobinemia
Acquired Methaemoglobinaemia
Bottom Line
View on ClinicalTrials.gov: NCT03395223 ↗Enrolled (actual)
7
Serious AEs
28.6%
Results posted
Apr 2023
Primary outcome: Primary: Primary Efficacy Endpoint: Number of Participants With and Without 50% Reduction in metHb Level — 3; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methylene Blue (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Provepharm SAS
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy Endpoint: Number of Participants With and Without 50% Reduction in metHb Level |
3; 3 | — |
| SECONDARY Number of Participants With and Without Concomitant Normalization of Respiratory Rate |
2; 2; 3 | — |
| SECONDARY Number of Participants With and Without Concomitant Normalization of Heart Rate |
2; 1; 4 | — |
| SECONDARY Number of Participants With and Without Concomitant Normalization of Blood Pressure |
2; 0; 5; 0; 1; 6 | — |
| SECONDARY Second Dose |
— | — |
| SECONDARY Number of Participants With Treatment-related Adverse Events |
0; 7 | — |
| SECONDARY Methylene Blue Content in Blood Samples |
— | — |
| SECONDARY Azure B Content in Blood Samples |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT03395223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.