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A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients With Sickle Cell Disease Who Are at Increased Risk for Primary Stroke

Study acronym: HIBISCUS 3
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion moved earlier from Sep 20, 2027 to Aug 20, 2027 Completion pushed from Sep 20, 2027 to Jun 28, 2028 · Study sites revised (9)v14 Show 2 more changesShow less
    • Completion pushed from Sep 20, 2027 to Jun 28, 2028
    • Study sites revised (9)

    See this version in full on ClinicalTrials.gov ↗

  2. Site details revised at 5 of 9 sitesv13
  3. Enrollment target: 46 to 27 Primary completion date: Jul 14, 2025 to Sep 20, 2027 · Completion date: May 18, 2026 to Sep 20, 2027 · Start date: Jul 19, 2023 to Jun 20, 2023 · 1 morev12 Show 4 more changesShow less
    • Primary completion date: Jul 14, 2025 to Sep 20, 2027
    • Completion date: May 18, 2026 to Sep 20, 2027
    • Start date: Jul 19, 2023 to Jun 20, 2023
    • Site details revised at 2 of 9 sites
  4. Primary endpoint revised Completion date: Oct 5, 2026 to May 18, 2026 · Start date: Jun 20, 2023 to Jul 19, 2023 · Eligibility criteria expanded, about 9 words · 3 morev11 Show 6 more changesShow less
    • Completion date: Oct 5, 2026 to May 18, 2026
    • Start date: Jun 20, 2023 to Jul 19, 2023
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints revised (2)
    • Study sites revised (9)
    • Collaborators shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Jan 31, 2025 to Jul 14, 2025 Completion date: Feb 28, 2026 to Oct 5, 2026v10 Show 1 more changeShow less
    • Completion date: Feb 28, 2026 to Oct 5, 2026
Show 8 earlier versionsHide 8 earlier versions
  1. Site details revised at 3 of 9 sitesv9
  2. Re-verified, no change to tracked fieldsv8
  3. Primary completion date: Oct 20, 2024 to Jan 31, 2025 Completion date: Aug 18, 2025 to Feb 28, 2026v7 Show 1 more changeShow less
    • Completion date: Aug 18, 2025 to Feb 28, 2026
  4. Study sites: 8 to 9v6
  5. Lead sponsor: Novo Nordisk A/S to Forma Therapeutics, Inc. Collaborators expanded, about 3 wordsv5 Show 1 more changeShow less
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv4
  7. Primary completion date: Jun 18, 2024 to Oct 20, 2024 Completion date: Jun 30, 2024 to Aug 18, 2025v3 Show 1 more changeShow less
    • Completion date: Jun 30, 2024 to Aug 18, 2025
  8. Study sites: 3 to 8v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
The study will test a new medicine, etavopivat, for sickle cell disease and see if it is safe and help-ful for participants with sickle cell disease who are at an increased risk of stroke. Participants will be divided into two cohorts depending on their transcranial doppler (TCD) ultrasound results and whether or not they receive hydroxyurea (medication that they may already be taking). In one cohort, participants with conditional transcranial doppler (TCD) or participants with abnormal TCD who are not able to receive hydroxyurea will be included. The study doctor will determine if the TCD result is conditional or abnormal. In another cohort, participants with conditional TCD or participants with abnormal TCD who are receiving a stable dose of hydroxyurea will be included. The study doctor will determine if the TCD result is conditional or abnormal. The participant will start a 52-week (1 year) treatment period. The participant will take 400 milligrams (mg) of etavopivat once a day for the 52 weeks. The dose of 400 mg will be taken as 2 tablets by mouth, each containing 200 mg of etavopivat. Etavopivat may be taken with or without food. Each dose should be taken with a glass of water. As part of the study, the participants will be asked to visit the clinic frequently. The participant will have the opportunity to participate in a 48-week optional extension treatment period. The optional extension treatment period will allow continued as-sessment of safety of etavopivat in paediatric patients. At the end of the study, if deemed appro-priate the participant, the caregiver, and the study doctor, the participant may be offered the op-portunity to participate in a separate study to continue receiving etavopivat. If/when this separate study becomes available, the participant may only transfer to the new study after completion of the 52-week primary treatment period and at any time during the 48-week optional extension treatment period.
Trial Details
NCT Number NCT05953584
Lead Sponsor Forma Therapeutics, Inc.
Conditions Sickle Cell Disease
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov