Last reviewed · How we verify
NCT03542760: metHb
Acquired Methemoglobinemia Observational Registry
trial testing Methylene Blue in Methemoglobinemia, Acquired in 24 participants. Completed in 31 August 2021.
30 June 2021
Quick facts
| Lead sponsor | Hospital Quality Foundation |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 24 |
| Start date | 31 May 2018 |
| Primary completion | 30 June 2021 |
| Estimated completion | 31 August 2021 |
| Sites | 32 locations across United States |
Drugs / interventions tested
- Methylene Blue (METHYLENE BLUE) — full drug profile →
Conditions studied
- Methemoglobinemia, Acquired — all drugs for Methemoglobinemia, Acquired →
- Methemoglobinemia — all drugs for Methemoglobinemia →
Sponsor
Hospital Quality Foundation
Who can join
Eligibility, any sex, with Methemoglobinemia, Acquired or Methemoglobinemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03542760
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Methylene Blue
Trials testing the same drug.
- NCT06052956 — Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses · Phase 2 · not yet recruiting
- NCT07494773 — Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection · Phase 1, PHASE2 · not yet recruiting
- NCT07040540 — Hemodynamic Effects of Intradermal Methylene Blue During Breast Surgery Under General Anesthesia · completed
- NCT07169487 — Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study · Phase 1 · recruiting
- NCT06900140 — Adjunctive Methylene Blue in Septic Shock · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03542760 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Quality Foundation
- Last refreshed: 12 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03542760.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing