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

NCT06923111 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2026-03-05

No results posted yet for this study

Summary

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

Interventions

DRUG

Xromi

Xromi is indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 9 months of age as part of standard clinical practice

Sponsors & Collaborators

  • OXON Epidemiology

    collaborator INDUSTRY

  • Nova Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Hussain Dr Mulla, PhD · Nova Laboratories Ltd.

  • Sara Dr Trompeter, MD · University College London Hospitals

Eligibility

Min Age
9 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-09
Primary Completion
2029-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06923111 on ClinicalTrials.gov