H-PRIME: Hydroxyurea - Pragmatic Reduction In Mortality and Economic burden

Imperial College0 个研究点目标入组 1,800 人开始时间: 2023年8月6日最近更新: 2024年3月4日

适应症

试验速览

暂无简介。

•?Aged 1-10 years inclusive
•?Confirmed SCD (either by HPLC or IEF at a qualified laboratory)
•?Have received conjugate pneumococcal vaccination against Hib and S. pneumoniae (otherwise eligible but unvaccinated children will be vaccinated through the study as above)
•?Carer willing/able to provide consent and to bring the child for follow-up visits, as demonstrated by either regular attendance at SCD clinics to date, or attending two visits (one of which may be the screening visit) before randomisation

•?Weighing <8kg – temporary exclusion pending the achievement of 8kg or more
•?Already meet criteria for starting hydroxyurea in national guidelines (frequent crises (>5/year), known abnormal transcranial Doppler ultrasound velocities, stroke or acute chest syndrome)
•?Already receiving hydroxyurea
•?Taking concomitant medications that are contraindicated with any of the trial medications (hydroxyurea, SP, DHA-PQP, penicillin V, cotrimoxazole) (including, but not limited to, nefazodone, verapamil, rifampicin, isoniazid, ethambutol)
•?A positive pregnancy test at screening or enrolment visits
•?Known cancer
•?A clinical history of previous or existing liver or renal diseases unrelated to sickle cell disease
•?Known cardiac ventricular dysfunction or failure or a previous history of cardiac arrhythmias
•?Known HIV (these children should receive cotrimoxazole prophylaxis and many will be receiving antiretrovirals that are contraindicated with one or more trial medications (zidovudine, amprenavir, atazanavir, indinavir, nelfinavir, ritonavir))
•?Current participation in any other clinical trial of an investigational medicinal product
•?Presence of acute infection on the day of screening (e.g. symptomatic P. falciparum malaria, pneumonia, septicaemia, meningitis, newly identified tuberculosis) – such children may be enrolled after recovery from an acute infection if they do not meet other exclusion criteria

发起方

Imperial College