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Acquired Methemoglobinemia Observational Registry

NCT03542760 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2023-04-12

No results posted yet for this study

Summary

This prospective, observational registry aims to collect real-world data regarding the safety and efficacy of ProvayBlue® (methylene blue 0.5%) used according to normal standard of care for the treatment of acquired methemoglobinemia. Methylene blue has been used for decades as a rescue medication for the treatment of methemoglobinemia, a rare and potentially life-threatening condition in which elevated levels of methemoglobin impede the delivery of oxygen from blood to body tissues. However, consistent prospective data about the safety and efficacy of this medication are sparse, simply because of the rarity of the disorder. ProvayBlue® received accelerated FDA approval for treatment of acquired methemoglobinemia in 2016. This large, prospective, multi-center observational registry has been initiated to gain more information on the use of methylene blue in the treatment of acquired methemoglobinemia.

Conditions

  • Methemoglobinemia, Acquired
  • Methemoglobinemia

Interventions

DRUG

Methylene Blue

Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care

Sponsors & Collaborators

  • Prove pharm

    collaborator INDUSTRY

  • Hospital Quality Foundation

    lead OTHER

Principal Investigators

  • Charles V Pollack, MD · Hospital Quality Foundation

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2021-06-30
Completion
2021-08-31

Countries

  • United States

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 NCT03542760 on ClinicalTrials.gov