A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease

Study acronym: Hibiscus 2
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 Show 4 more changesShow less
    • Enrollment increased: 408 → 510 participants
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: details revised at 7 of 10 entries
    • Site details revised at 35 of 175 sites
  2. Study completion pushed from Mar 12, 2029 to Aug 12, 2029
    • Study sites: 174 to 175
    v20
  3. Study sites: 172 to 174v19
  4. Study sites revised (172)v18
  5. Study sites: 170 to 172v17
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites revised (170)v16
  2. Study sites: 169 to 170v15
  3. Study sites: 165 to 169
    • Study completion date: Apr 27, 2029 to Mar 12, 2029
    • Secondary endpoints: 14 to 10
    v14
  4. Study sites: 163 to 165
    • Study completion date: Sep 22, 2028 to Apr 27, 2029
    v13
  5. Study sites: 161 to 163v12
  6. Site details revised at 1 of 161 sitesv11
  7. Study sites: 160 to 161v10
  8. Primary endpoints: 4 to 1
    • Secondary endpoints: 11 to 14
    • Site details revised at 5 of 160 sites
    • Study title shortened, about 1 word
    v9
  9. Study sites: 159 to 160v8
  10. Study sites: 158 to 159v7
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 154 to 158
    • Start date changed from estimate of Dec 18, 2024 to Feb 17, 2025
    v6
  12. Study sites: 136 to 154
    • Start date: Dec 16, 2024 to Dec 18, 2024
    v5
  13. Study sites: 133 to 136v4
  14. Study sites: 130 to 133v3
  15. Primary completion date: Dec 15, 2025 to Aug 27, 2027
    • Study sites: 129 to 130
    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.
This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.
Trial Details
NCT Number NCT06612268
Lead Sponsor Novo Nordisk A/S
Conditions
(from sponsor)		 Sickle Cell Disease
Related terms Anemia, Sickle Cell
Enrollment 510 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov