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

Study acronym: FLORAL
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Lead sponsor: Novo Nordisk A/S to Novo Nordisk A/S
    • Study sites: 106 to 107
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 8 entries
  2. Study sites: 105 to 106v14
  3. Study sites: 103 to 105v13
  4. Site details revised at 7 of 103 sitesv12
  5. Study sites: 104 to 103v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 103 to 104v10
  2. Study sites: 101 to 103v9
  3. Study sites: 100 to 101v8
  4. Primary and study completion dates: Nov 30, 2029 to Dec 30, 2030v7 Show 5 more changesShow less
    • Enrollment target: 325 to 480
    • Study sites: 96 to 100
    • Interventions: Etavopivat A (Drug), Etavopivat B (Drug) to Etavopivat A (Drug), Etavopivat B (Drug), Etavopivat C (Drug)
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: details revised at 8 of 8 entries
  5. Site details revised at 1 of 96 sitesv6
  6. Study sites: 94 to 96v5
  7. Study sites: 91 to 94v4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 58 to 91
    • Start date changed from estimate of Dec 9, 2024 to Jan 10, 2025
    v3
  9. Study sites: 55 to 58
    • Start date: Nov 15, 2024 to Dec 9, 2024
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novo Nordisk
269 trials monitored
See 14 trials at risk
Sickle Cell Disease
375 trials monitored
See 25 trials at risk
Thalassemia
163 trials monitored
See 4 trials at risk
Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. Haemoglobin is the protein that carries oxygen through the body. This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. The study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.
Trial Details
NCT Number NCT06609226
Lead Sponsor Novo Nordisk A/S
Conditions
(from sponsor)		 Sickle Cell Disease, Thalassemia
Related terms Anemia, Sickle Cell, Thalassemia
Enrollment 480 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov