A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia

NCT06609226 · FLORAL Phase 3Recruiting

Lead sponsor
Novo Nordisk A/S (Industry)
Enrollment
480 (estimated)
Start date
10 Jan 2025
Primary completion
30 Dec 2030 (estimated)
Study completion
30 Dec 2030
Last update posted
18 Sep 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Non randomized
Intervention model
Parallel
Masking
None
Arms
5

Interventions

  • Etavopivat A Drug
  • Etavopivat B Drug
  • Etavopivat C Drug

Conditions and primary outcome

  • Sickle Cell Disease
  • Thalassemia

Primary outcome

Number of treatment emergent adverse events (TEAEs), reported for each indication and age group separately (Baseline (week 0 of FLORAL) up to end of study (up to week 316)); Number of adverse reactions, reported for each indication and age group separately (Baseline (week 0 of FLORAL) up to end of study (up to week 316))

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT06609226.

CT-VCA trial quality

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Data integrity

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Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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