Clinical Trial

PASS of Xromi Comparing Safety and Effectiveness in Children Under 2 Years With Sickle Cell Disease [PRECISE PASS]

Study acronym: PRECISE
Recruiting
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Summary
This post-authorisation safety and efficacy study (PRECISE PASS) evaluates the use of Xromi® (hydroxycarbamide 100 mg/mL oral solution) in children aged 9 months to under 2 years with sickle cell disease (SCD). The objective is to assess the safety profile and clinical effectiveness of Xromi® under routine clinical conditions. The study includes a prospective cohort of Xromi®-treated patients and a matched retrospective comparator cohort of untreated patients. Participants will be followed for 24 months from treatment initiation or matched index date.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-04-03; most recent amendment 2026-03-03.
Status change: Not Yet Recruiting → Recruiting 2025-05-13
Trial Details
NCT Number NCT06923111
Lead Sponsor Nova Laboratories Limited
Collaborators: OXON Epidemiology
Conditions Sickle Cell Disease
Enrollment 180 participants
Start Date 2025-06-09
Primary Completion 2029-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-03-05