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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
Sponsor:
Information provided by (Responsible Party):
Provepharm SAS

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
Acquired Methaemoglobinaemia Drug: Methylene Blue Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 Name: ProvayBlue




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Concomitant vital signs normalization [ Time Frame: 2 hours ]
    Normalization of the respiratory rate within 2 hours of the first dose of ProvayBlue

  2. Concomitant vital signs normalization [ Time Frame: 2 hours ]
    Normalization of the heart rate within 2 hours of the first dose of ProvayBlue

  3. Concomitant vital signs normalization [ Time Frame: 2 hours ]
    Normalization of the blood pressure standard values within 2 hours of the first dose of ProvayBlue

  4. Second dose [ Time Frame: 1 hour ]
    Evaluation of the patients who achieve a 50% reduction in metHb level after a second dose of ProvayBlue

  5. Number of participants with treatment-related adverse events [ Time Frame: 24 hours ]
    The AEs will be assessed.

  6. Methylene Blue content in blood samples [ Time Frame: 24 hours ]
    Blood samples will be analyzed for methylene blue content

  7. Azure B content in blood samples [ Time Frame: 24 hours ]
    Blood samples will be analyzed for Azure B content



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395223


Contacts
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Contact: Emilie Huyghues des Etages, Engineer 00 33 4 91 08 69 30 emilie.huyghues@provepharm.com
Contact: Pablo Gluschankof, PhD 00 33 4 91 08 69 30 pablo.gluschankof@provepharm.com

Locations
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France
Hôpital Lariboisière Recruiting
Paris, France, 75475
Contact: Bruno Megarbane, PhD         
Sponsors and Collaborators
Provepharm SAS
Investigators
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Principal Investigator: Bruno Megarbane Hôpital Lariboisière
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Responsible Party: Provepharm SAS
ClinicalTrials.gov Identifier: NCT03395223    
Other Study ID Numbers: PVP-2016003
2017-000290-37 ( EudraCT Number )
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Provepharm SAS:
Acquired Methaemoglobinemia
Methylene Blue
Additional relevant MeSH terms:
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Methemoglobinemia
Hematologic Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action