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A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease

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

Record History

  1. Eligibility criteria expanded, about 30 words Secondary endpoints: details revised at 1 of 10 entries · Site details revised at 6 of 18 sites · Collaborators: details revised at 1 of 1 entry Show 3 more changesShow less
    • Secondary endpoints: details revised at 1 of 10 entries
    • Site details revised at 6 of 18 sites
    • Collaborators: details revised at 1 of 1 entry
  2. Trial arms changed: 1 → 4 Study sites revised (18) · Collaborator revisedv14 Show 2 more changesShow less
    • Study sites revised (18)
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment increased: 50 → 95 participants Eligibility criteria expanded, about 160 words · Study sites revised (18)v13 Show 2 more changesShow less
    • Eligibility criteria expanded, about 160 words
    • Study sites revised (18)

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 16 to 18v12
  5. Primary completion date: Aug 8, 2029 to Feb 23, 2028 Study sites: 15 to 16v11 Show 1 more changeShow less
    • Study sites: 15 to 16
Show 9 earlier versionsHide 9 earlier versions
  1. Start date: Aug 29, 2023 to Jan 12, 2023 Site details revised at 1 of 15 sitesv10 Show 1 more changeShow less
    • Site details revised at 1 of 15 sites
  2. Start date: Feb 3, 2023 to Aug 29, 2023 Primary completion date: Feb 26, 2029 to Aug 8, 2029 · Completion date: Aug 13, 2029 to Aug 8, 2029 · Site details revised at 2 of 15 sitesv9 Show 3 more changesShow less
    • Primary completion date: Feb 26, 2029 to Aug 8, 2029
    • Completion date: Aug 13, 2029 to Aug 8, 2029
    • Site details revised at 2 of 15 sites
  3. Phase: Phase 1/2 to Phase 2 Study sites: 14 to 15 · Completion date: Jun 15, 2029 to Aug 13, 2029 · Start date: Feb 7, 2023 to Feb 3, 2023v8 Show 3 more changesShow less
    • Study sites: 14 to 15
    • Completion date: Jun 15, 2029 to Aug 13, 2029
    • Start date: Feb 7, 2023 to Feb 3, 2023
  4. Study sites: 13 to 14v7
  5. Primary completion date: Jan 20, 2026 to Feb 26, 2029 Study sites: 7 to 13 · Completion date: Jan 20, 2026 to Jun 15, 2029v6 Show 2 more changesShow less
    • Study sites: 7 to 13
    • Completion date: Jan 20, 2026 to Jun 15, 2029
  6. Study Identification, Study Statusv5
  7. Re-verified, no change to tracked fieldsv4
  8. Primary and study completion dates: Sep 12, 2026 to Jan 20, 2026v3
  9. Trial status: Active, Not Recruiting to Recruiting Study sites: 1 to 7v2 Show 1 more changeShow less
    • Study sites: 1 to 7
  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 purpose of this study is to evaluate the pharmacokinetics and safety of etavopivat in paediatric participants with sickle cell disease (SCD). Participants will receive etavopivat and will be enrolled in a staggered manner, starting with the oldest age group and followed sequentially by younger cohorts after review of pharmacokinetic and safety data from the preceding cohort. All participants will undergo a 24-week primary treatment period followed by a 72-week extension treatment period to further evaluate long-term safety and pharmacokinetics of etavopivat. The total duration of the study will be approximately 96 weeks.
Trial Details
NCT Number NCT06198712
Lead Sponsor Forma Therapeutics, Inc.
Collaborators: Novo Nordisk A/S. This study is currently undergoing a sponsor transition from Forma Therapeutics, Inc. to Novo Nordisk A/S.
Conditions Sickle Cell Disease
Enrollment 95 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov