MEthylene Blue In Patients With Acquired Methemoglobinemia

NCT03395223 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: PVP-20160032017-000290-37
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Methaemoglobinaemia

Keywords

Acquired Methaemoglobinemia; Methylene Blue

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour

Secondary Outcomes (7)

• Number of Participants With and Without Concomitant Normalization of Respiratory Rate

  2 hours

• Number of Participants With and Without Concomitant Normalization of Heart Rate

  2 hours

• Number of Participants With and Without Concomitant Normalization of Blood Pressure

  2 hours

• Second Dose

  1 hour

• Number of Participants With Treatment-related Adverse Events

  24 hours

Study Arms (1)

ProvayBlue (Methylene Blue) arm

EXPERIMENTAL

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

Interventions

Methylene Blue DRUG

Administration of Methylene Blue to treat acquired methaemoglobinaemia

Also known as: ProvayBlue

ProvayBlue (Methylene Blue) arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Provepharm SAS: lead

Study Sites (1)

Hôpital Lariboisière

Paris, 75475, France

Location

MeSH Terms

Interventions

Methylene Blue

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

This study experienced a slow pace of enrollment leading to enrollment being closed prior to completing enrollment of the planned sample size of 10 subjects. Additionally, the nature of the disease and indication, necessitated that the subject's treatment with ProvayBlue was per the investigator's standard care and could have occurred prior to or after the PICD was signed. This frequently prevented the collection of pharmacokinetic (PK) blood draws and study specific evaluations on schedule.

Results Point of Contact

• Title: Emilie HUYGHUES
• Organization: Provepharm SAS

emilie.huyghues@provepharm.com

+33 6 20 58 28 27

Study Officials

• Bruno Megarbane

  Hôpital Lariboisière

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 10, 2018
• Study Start: July 6, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: April 10, 2023
• Results First Posted: April 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)