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Study identifier: NCT06923111 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Sickle Cell Disease  ·  Sponsor: Nova Laboratories Limited

PhaseN/A
Planned participants180
Who can joinAll sexes, 9 Months to 23 Months
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Hussain Mulla, PhD  ·  +44 (0)116 223 0100  ·  hussain.mulla@novalabs.co.uk

Sarah Edwards, PhD  ·  +44 (0)116 223 0100  ·  sarah.edwards@novalabs.co.uk

Always discuss trial participation with your own doctor first.

Locations (12)

Universitätsklinikum Hamburg-EppendorfHamburg, GermanyRecruiting
Universitätsklinikum HeidelbergHeidelberg, GermanyRecruiting
Basildon University HospitalBasildon, United KingdomRecruiting
Noah's Ark Children's Hospital for WalesCardiff, United KingdomRecruiting
Evelina London Children's HospitalLondon, United KingdomRecruiting
Kings College HospitalLondon, United KingdomRecruiting
North Middlesex University HospitalLondon, United KingdomRecruiting
The Royal London HospitalLondon, United KingdomRecruiting
University College London HospitalLondon, United KingdomRecruiting
Whittington HospitalLondon, United KingdomRecruiting
Royal Manchester Children's HospitalManchester, United KingdomRecruiting
John Radcliffe HospitalOxford, United KingdomRecruiting

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Source record: clinicaltrials.gov/study/NCT06923111