Sickle Cell Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

This trial has two groups: one group receiving a new medicine (Xromi®), and a comparison group not receiving it. Criteria for each are listed below.

Group 1 – Children prescribed Xromi®:

• Children aged 9 months to under 2 years old at the time they enter the study
• Children who have been diagnosed with sickle cell disease (SCD)
• Children whose specific type of sickle cell disease (based on a gene test called β-globin genotype) is already known
• Children who have been prescribed Xromi® by their doctor to help prevent complications of SCD
• Children whose parent or legal guardian provides written consent for them to take part (some hospitals may accept a broader consent already given for research)

Group 2 – Comparison group (not receiving Xromi®):

• Children aged 9 months to under 2 years old at the time they enter the study
• Children who have been diagnosed with sickle cell disease (SCD)
• Children whose specific type of sickle cell disease (based on a β-globin genotype test) is already known
• Children who are matched by the trial team to a child in Group 1
• Children whose parent or legal guardian provides written consent for them to take part

Who may not be able to join:

Group 1 – Children prescribed Xromi®:

• Children who have previously taken hydroxycarbamide (the medicine in Xromi®) in any form before entering the study
• Children who are already receiving regular blood transfusions every 8 weeks or more frequently
• Children known to have had an allergic reaction to any ingredient in Xromi®
• Children with severely reduced liver function, severely reduced kidney function, or certain abnormal blood test results (low white blood cell counts, low reticulocyte counts, or low platelet counts) — (confirm specific thresholds with trial site)
• Children already taking part in another clinical trial of an investigational medicine
• Children currently taking anti-HIV (antiretroviral) medicines
• Children with an active cancer diagnosis
• Children who are prescribed Xromi® but do not actually start taking it will also be removed from the study data

Group 2 – Comparison group:

• Children who have taken hydroxycarbamide in any form at any point before or at the time of entering the study
• Children who are already receiving regular blood transfusions every 8 weeks or more frequently
• Children with severely reduced liver function, severely reduced kidney function, or certain abnormal blood test results (low white blood cell counts, low reticulocyte counts, or low platelet counts) — (confirm specific thresholds with trial site)
• Children already taking part in another clinical trial of an investigational medicine
• Children currently taking anti-HIV (antiretroviral) medicines
• Children with an active cancer diagnosis

Important: Always verify eligibility with the trial site directly before applying.