Back to resultsMEthylene Blue In Patients With Acquired Methemoglobinemia (MEBIPAM)
Primary Purpose
Acquired Methaemoglobinaemia
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Methylene Blue
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Methaemoglobinaemia focused on measuring Acquired Methaemoglobinemia, Methylene Blue
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.
Sites / Locations
- Hôpital Lariboisière
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ProvayBlue (Methylene Blue) arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Primary Efficacy Endpoint: Number of Participants With and Without 50% Reduction in metHb Level
A 50% reduction in metHb level within 1 hour of the first dose of ProvayBlue for treatment of acquired methemoglobinemia. The timing of postdosing metHb level assays is inconsistent in clinical practice, for that reason metHb level at 1-hour postdosing was derived using linear interpolation.
Secondary Outcome Measures
Number of Participants With and Without Concomitant Normalization of Respiratory Rate
Normalization of the respiratory rate within 2 hours of the first dose of ProvayBlue. The normal range used for respiratory rate was 12-20 breaths per minute.
Number of Participants With and Without Concomitant Normalization of Heart Rate
Normalization of the heart rate within 2 hours of the first dose of ProvayBlue. The normal range used for heart rate was 50-100 beats per minute.
Number of Participants With and Without Concomitant Normalization of Blood Pressure
Normalization of blood pressure standard values within 2 hours of the first dose of ProvayBlue. The normal range used for systolic blood pressure was was 90-140 mm HG and the normal range used for diastolic blood pressure was 60-90 mm HG.
Second Dose
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
Number of participants who experience a treatment emergent adverse event assessed by the investigator as being related to study drug..
Methylene Blue Content in Blood Samples
Blood samples will be analyzed for methylene blue content
Azure B Content in Blood Samples
Blood samples will be analyzed for Azure B content
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03395223
Brief Title
MEthylene Blue In Patients With Acquired Methemoglobinemia
Acronym
MEBIPAM
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 6, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Provepharm SAS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Methaemoglobinaemia
Keywords
Acquired Methaemoglobinemia, Methylene Blue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ProvayBlue (Methylene Blue) arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylene Blue
Other Intervention Name(s)
ProvayBlue
Intervention Description
Administration of Methylene Blue to treat acquired methaemoglobinaemia
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint: Number of Participants With and Without 50% Reduction in metHb Level
Description
A 50% reduction in metHb level within 1 hour of the first dose of ProvayBlue for treatment of acquired methemoglobinemia. The timing of postdosing metHb level assays is inconsistent in clinical practice, for that reason metHb level at 1-hour postdosing was derived using linear interpolation.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Number of Participants With and Without Concomitant Normalization of Respiratory Rate
Description
Normalization of the respiratory rate within 2 hours of the first dose of ProvayBlue. The normal range used for respiratory rate was 12-20 breaths per minute.
Time Frame
2 hours
Title
Number of Participants With and Without Concomitant Normalization of Heart Rate
Description
Normalization of the heart rate within 2 hours of the first dose of ProvayBlue. The normal range used for heart rate was 50-100 beats per minute.
Time Frame
2 hours
Title
Number of Participants With and Without Concomitant Normalization of Blood Pressure
Description
Normalization of blood pressure standard values within 2 hours of the first dose of ProvayBlue. The normal range used for systolic blood pressure was was 90-140 mm HG and the normal range used for diastolic blood pressure was 60-90 mm HG.
Time Frame
2 hours
Title
Second Dose
Description
Evaluation of the patients who achieve a 50% reduction in metHb level after a second dose of ProvayBlue
Time Frame
1 hour
Title
Number of Participants With Treatment-related Adverse Events
Description
Number of participants who experience a treatment emergent adverse event assessed by the investigator as being related to study drug..
Time Frame
24 hours
Title
Methylene Blue Content in Blood Samples
Description
Blood samples will be analyzed for methylene blue content
Time Frame
24 hours
Title
Azure B Content in Blood Samples
Description
Blood samples will be analyzed for Azure B content
Time Frame
24 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Megarbane
Organizational Affiliation
Hôpital Lariboisière
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75475
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MEthylene Blue In Patients With Acquired Methemoglobinemia
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