CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 7 enrolled
Drug / intervention
Methylene Bluedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03395223
NCT03395223Phase 4Completed
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Open Label Clinical Study to Evaluate the Safety and Efficacy of ProvayBlueTM (Methylene Blue) for the Treatment of Acquired Methemoglobinemia

Provepharm SAS·interventional·Posted Jan 10, 2018·Updated Apr 10, 2023

In Brief

A Phase 4 clinical trial evaluating Methylene Blue for Acquired Methaemoglobinaemia. Completed, enrolled 7 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcquired Methaemoglobinaemia
CountriesFrance
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJan 10, 2018
Enrollment StartJul 6, 2018
Primary CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.5 years ago

Interventions

Methylene Bluedrug

Administration of Methylene Blue to treat acquired methaemoglobinaemia