MEBIPAM: MEthylene Blue In Patients With Acquired Methemoglobinemia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Methylene Blue
Administration of Methylene Blue to treat acquired methaemoglobinaemia
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Primary Efficacy endpoint: 50% reduction in metHb level [1 hour]
A 50% reduction in metHb level within 1 hour of the first dose of ProvayBlue for treatment of acquired methemoglobinemia.
Secondary Outcome Measures
- Concomitant vital signs normalization [2 hours]
Normalization of the respiratory rate within 2 hours of the first dose of ProvayBlue
- Concomitant vital signs normalization [2 hours]
Normalization of the heart rate within 2 hours of the first dose of ProvayBlue
- Concomitant vital signs normalization [2 hours]
Normalization of the blood pressure standard values within 2 hours of the first dose of ProvayBlue
- Second dose [1 hour]
Evaluation of the patients who achieve a 50% reduction in metHb level after a second dose of ProvayBlue
- Number of participants with treatment-related adverse events [24 hours]
The AEs will be assessed.
- Methylene Blue content in blood samples [24 hours]
Blood samples will be analyzed for methylene blue content
- Azure B content in blood samples [24 hours]
Blood samples will be analyzed for Azure B content
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Lariboisière | Paris | France | 75475 |
Sponsors and Collaborators
- Provepharm SAS
Investigators
- Principal Investigator: Bruno Megarbane, Hôpital Lariboisière
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PVP-2016003
- 2017-000290-37