Actively Recruiting
PASS of Xromi Comparing Safety and Effectiveness in Children Under 2 Years With Sickle Cell Disease [PRECISE PASS]
Led by Nova Laboratories Limited · Updated on 2026-03-05
180
Participants Needed
12
Research Sites
207 weeks
Total Duration
On this page
Sponsors
N
Nova Laboratories Limited
Lead Sponsor
O
OXON Epidemiology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PASS of Xromi Comparing Safety and Effectiveness in Children Under 2 Years With Sickle Cell Disease [PRECISE PASS]
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged from 9 months to under 2 years at the index date
- Diagnosis of sickle cell disease
- Known beta-globin genotype at the index date
- Prescribed Xromi4 for the prevention of complications of sickle cell disease
- Parent or legal representative provides written informed consent to participate in the study
You will not qualify if you...
- Previous use of hydroxycarbamide of any formulation before the index date
- Receiving regular blood transfusions occurring every 8 weeks or more frequently at the index date
- Known hypersensitivity to any excipients of Xromi4 at the index date
- Severe hepatic impairment (Child-Pugh classification C) at the index date
- Severe renal impairment (creatinine clearance less than 30 ml/min) at the index date
- Absolute neutrophil count less than 1.0 x 10^9/L at the index date
- Absolute reticulocyte count less than 80 x 10^9/L at the index date
- Platelets less than 80 x 10^9/L at the index date
- Participating in another clinical study of an investigational medicinal product at the index date
- Use of anti-retroviral medicinal products for HIV at the index date
- Active malignancy at the index date
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
2
Universitätsklinikum Heidelberg
Heidelberg, Germany
Actively Recruiting
3
Basildon University Hospital
Basildon, United Kingdom
Actively Recruiting
4
Noah's Ark Children's Hospital for Wales
Cardiff, United Kingdom
Actively Recruiting
5
Evelina London Children's Hospital
London, United Kingdom
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6
Kings College Hospital
London, United Kingdom
Actively Recruiting
7
North Middlesex University Hospital
London, United Kingdom
Actively Recruiting
8
The Royal London Hospital
London, United Kingdom
Actively Recruiting
9
University College London Hospital
London, United Kingdom
Actively Recruiting
10
Whittington Hospital
London, United Kingdom
Actively Recruiting
11
Royal Manchester Children's Hospital
Manchester, United Kingdom
Actively Recruiting
12
John Radcliffe Hospital
Oxford, United Kingdom
Actively Recruiting
Research Team
H
Hussain Mulla, PhD
CONTACT
S
Sarah Edwards, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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