Primary outcomeCount of participants· 1 hour
Primary Efficacy Endpoint: Number of Participants With and Without 50% Reduction in metHb Level
| Group | Value (Participants) |
|---|---|
| ProvayBlue (Methylene Blue) Arm | 3 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataMEthylene Blue In Patients With Acquired Methemoglobinemia
Short name MEBIPAM
NCTNCT03395223 (opens ClinicalTrials.gov in a new tab)Other idPVP-2016003Other id2017-000290-37Other id2017
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 7 participants (actual)
- Sponsor
- Provepharm SAS · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
France
- Start
- 6 Jul 2018
- Primary completion
- 31 Aug 2020
- Completion
- 31 Aug 2020
- First posted
- 10 Jan 2018
- Last update posted
- 10 Apr 2023
- Conditions
- Acquired Methaemoglobinaemia
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2018201920202021
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Methylene BlueDrug
Arms1
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Primary Efficacy Endpoint: Number of Participants With and Without 50% Reduction in metHb Level
Time frame · 1 hour
Registry 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.
Secondary outcomes(7)
Number of Participants With and Without Concomitant Normalization of Respiratory Rate
Time frame · 2 hours
Registry 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.
Number of Participants With and Without Concomitant Normalization of Heart Rate
Time frame · 2 hours
Registry 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.
Number of Participants With and Without Concomitant Normalization of Blood Pressure
Time frame · 2 hours
Registry 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.
Second Dose
Time frame · 1 hour
Registry description
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
Registry description
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
Time frame · 24 hours
Registry description
Blood samples will be analyzed for methylene blue content
Azure B Content in Blood Samples
Time frame · 24 hours
Registry description
Blood samples will be analyzed for Azure B content
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeCount of participants· 2 hours
Number of Participants With and Without Concomitant Normalization of Respiratory Rate
| Group | Value (Participants) |
|---|---|
| ProvayBlue (Methylene Blue) Arm | 2 |
Secondary outcomeCount of participants· 2 hours
Number of Participants With and Without Concomitant Normalization of Heart Rate
| Group | Value (Participants) |
|---|---|
| ProvayBlue (Methylene Blue) Arm | 2 |
Secondary outcomeCount of participants· 2 hours
Number of Participants With and Without Concomitant Normalization of Blood Pressure
| Group | Value (Participants) |
|---|---|
| ProvayBlue (Methylene Blue) Arm | 2 |
Secondary outcome· 1 hour
Second Dose
| Group | Value |
|---|---|
| ProvayBlue (Methylene Blue) Arm | not posted |
Secondary outcomeCount of participants· 24 hours
Number of Participants With Treatment-related Adverse Events
| Group | Value (Participants) |
|---|---|
| ProvayBlue (Methylene Blue) Arm | 0 |
Secondary outcome· 24 hours
Methylene Blue Content in Blood Samples
| Group | Value |
|---|---|
| ProvayBlue (Methylene Blue) Arm | not posted |
Secondary outcome· 24 hours
Azure B Content in Blood Samples
| Group | Value |
|---|---|
| ProvayBlue (Methylene Blue) Arm | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ProvayBlue (Methylene Blue) ArmMethylene 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. Methylene Blue: Administration of Methylene Blue to treat acquired methaemoglobinaemia | 0 / 7 | 2 / 7 | 0 / 7 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- Not stated
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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