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MEthylene Blue In Patients With Acquired Methemoglobinemia

NCT03395223 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-04-10

Study results available
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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

Interventions

DRUG

Methylene Blue

Administration of Methylene Blue to treat acquired methaemoglobinaemia

Sponsors & Collaborators

  • Provepharm SAS

    lead INDUSTRY

Principal Investigators

  • Bruno Megarbane · Hôpital Lariboisière

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-06
Primary Completion
2020-08-31
Completion
2020-08-31
FDA Drug
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03395223 on ClinicalTrials.gov