Condition: Sickle Cell Disease · Sponsor: Nova Laboratories Limited
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.
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.
| Universitätsklinikum Hamburg-Eppendorf | Hamburg, Germany | Recruiting |
| Universitätsklinikum Heidelberg | Heidelberg, Germany | Recruiting |
| Basildon University Hospital | Basildon, United Kingdom | Recruiting |
| Noah's Ark Children's Hospital for Wales | Cardiff, United Kingdom | Recruiting |
| Evelina London Children's Hospital | London, United Kingdom | Recruiting |
| Kings College Hospital | London, United Kingdom | Recruiting |
| North Middlesex University Hospital | London, United Kingdom | Recruiting |
| The Royal London Hospital | London, United Kingdom | Recruiting |
| University College London Hospital | London, United Kingdom | Recruiting |
| Whittington Hospital | London, United Kingdom | Recruiting |
| Royal Manchester Children's Hospital | Manchester, United Kingdom | Recruiting |
| John Radcliffe Hospital | Oxford, United Kingdom | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06923111