Pharmacokinetics, Efficacy and Safety of Twice Daily Dosing Regimen of Hydroxycarbamide Dispersible Tablets in Children With Sickle Cell Disease

Study acronym: KID-BID
StatusRecruiting
PhasePhase 2
SponsorTheravia
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Feb 2027 → Feb 2028
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Record History

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  1. Primary and study completion pushed from Feb 2027 to Feb 2028
    • Study sites: 6 to 7
    • Eligibility criteria expanded, about 18 words
  2. Primary and study completion dates: Aug 2026 to Feb 2027
    • Site details revised at 3 of 6 sites
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Sep 2024 to Jan 21, 2025
    • Study sites: 4 to 6
    • Primary and study completion dates: Apr 2026 to Aug 2026
    • Eligibility criteria expanded, about 9 words
  4. 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.
Theravia
3 trials monitored
See 1 trial at risk
Sickle Cell Disease
374 trials monitored
See 24 trials at risk
The purpose of this interventional, phase II, national, multicentric, non-randomised, open-label study is to evaluate the pharmacokinetics (PK), efficacy and safety of Hydroxycarbamide Paediatric dispersible tablets with a twice daily dosing regimen in children with Sickle Celle Disease between 9 months to 11 years of age. Participants will: * Take Hydroxycarbamide twice a day every day for 12 months * Visit the clinic at screening, baseline, 1, 3, 6, 9 and 12 months
Trial Details
NCT Number NCT06578507
Lead Sponsor Theravia
Conditions
(from sponsor)		 Sickle Cell Disease
Related terms Anemia, Sickle Cell
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov