PASS of Xromi Comparing Safety and Effectiveness in Children Under 2 Years With Sickle Cell Disease [PRECISE PASS]
Recruiting now
Conditions studied: Sickle Cell Disease
In brief
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.
Key facts
- Study ID
- NCT06923111
- Run by
- Nova Laboratories Limited
- People needed
- 180
- Starts
- 2025-06-09
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-03-05
Who can join
Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (enrolling)
- Universitätsklinikum Heidelberg — Heidelberg, Germany (enrolling)
- Basildon University Hospital — Basildon, United Kingdom (enrolling)
- Noah's Ark Children's Hospital for Wales — Cardiff, United Kingdom (enrolling)
- Evelina London Children's Hospital — London, United Kingdom (enrolling)
- Kings College Hospital — London, United Kingdom (enrolling)
- North Middlesex University Hospital — London, United Kingdom (enrolling)
- The Royal London Hospital — London, United Kingdom (enrolling)
- University College London Hospital — London, United Kingdom (enrolling)
- Whittington Hospital — London, United Kingdom (enrolling)
- Royal Manchester Children's Hospital — Manchester, United Kingdom (enrolling)
- John Radcliffe Hospital — Oxford, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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