Clinical study to find out whether methylene blue injection is safe and effective in the treatment of a blood disorder (methemoglobinemia) resulting from exposure to toxic agents (drugs or environmental poisons)

Phase 1

• Conditions: Acquired methemoglobinemia; MedDRA version: 20.0Level: LLTClassification code 10054290Term: Acquired methemoglobinemiaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2017-000290-37-GB
• Lead Sponsor: Provepharm SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-30
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Paediatric 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.).
2. Written informed consent obtained prior to any data collection (retrospective and prospective) for this study and study specific assessments.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1. Known severe hypersensitivity reactions to methylene blue or any other thiazine dye;
2. Known deficiency in glucose-6-phosphate dehydrogenase (G6PD) due to the risk of hemolytic anemia as well as lack of therapeutic effect;
3. Known deficiency in Nicotinamide Adenine Dinucleotide Phosphate Hydrogen (NADPH) reductase.
4. Known use of selective serotonin reuptake inhibitors (SSRIs), serotonin and norephinephrine reuptake inhibitors (SNRIs), MonoAmine Oxidase (MAO) inhibitors or drugs metabolised via CYP isoenzymes anticipated during the treatment phase of the study.
5. Women who refuse to stop breastfeeding for up to 8 days after receiving the last dose of ProvayBlue.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified