U.S., April 12 -- ClinicalTrials.gov registry received information related to the study (NCT06923111) titled 'PASS of Xromi Comparing Safety and Effectiveness in Children Under 2 Years With Sickle Cell Disease [PRECISE PASS]' on April 03.
Brief Summary: This post-authorisation safety and efficacy study (PRECISE PASS) evaluates the use of Xromi(R) (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(R) under routine clinical conditions. The study includes a prospective cohort of Xromi(R)-treated patients and a matched retrospective comparator cohort of untreated patients. Participants will be fo...