MEthylene Blue In Patients With Acquired Methemoglobinemia (MEBIPAM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03395223|
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : March 4, 2020
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|
|Acquired Methaemoglobinaemia||Drug: Methylene Blue||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Clinical Study to Evaluate the Safety and Efficacy of ProvayBlueTM (Methylene Blue) for the Treatment of Acquired Methemoglobinemia|
|Actual Study Start Date :||July 6, 2018|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2020|
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 Name: ProvayBlue
- Primary Efficacy endpoint: 50% reduction in metHb level [ Time Frame: 1 hour ]A 50% reduction in metHb level within 1 hour of the first dose of ProvayBlue for treatment of acquired methemoglobinemia.
- Concomitant vital signs normalization [ Time Frame: 2 hours ]Normalization of the respiratory rate within 2 hours of the first dose of ProvayBlue
- Concomitant vital signs normalization [ Time Frame: 2 hours ]Normalization of the heart rate within 2 hours of the first dose of ProvayBlue
- Concomitant vital signs normalization [ Time Frame: 2 hours ]Normalization of the blood pressure standard values within 2 hours of the first dose of ProvayBlue
- Second dose [ Time Frame: 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 [ Time Frame: 24 hours ]The AEs will be assessed.
- Methylene Blue content in blood samples [ Time Frame: 24 hours ]Blood samples will be analyzed for methylene blue content
- Azure B content in blood samples [ Time Frame: 24 hours ]Blood samples will be analyzed for Azure B content
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395223
|Contact: Emilie Huyghues des Etages, Engineer||00 33 4 91 08 69 firstname.lastname@example.org|
|Contact: Pablo Gluschankof, PhD||00 33 4 91 08 69 email@example.com|
|Paris, France, 75475|
|Contact: Bruno Megarbane, PhD|
|Principal Investigator:||Bruno Megarbane||Hôpital Lariboisière|