The Growth Hormone Deficiency Reversal Trial: Effect on final height of discontinuation vs continuation of growth hormone treatment in pubertal children with isolated growth hormone deficiency – A non-inferiority randomised controlled trial - NIHR127468

niversity College London0 个研究点目标入组 40 人开始时间: 2022年11月15日最近更新: 2024年7月22日

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•Children (8-15 years of age for girls, 9-17 years of age for boys) with reversed Isolated Growth Hormone Deficiency (I-GHD) in established puberty (Tanner stages B2/3 in girls & 6-12ml testes in boys) and normal brain Magnetic Resonance Imaging (MRI) scan result (incl. small anterior pituitary). Children will need to have completed a minimum 6-week period of discontinuation of GH medication prior to a GH re-test. Children demonstrating GHD reversal (defined as a peak stimulated GH equal to or greater than 6.7 µg/L using arginine or insulin tolerance test) will be eligible to participate in this trial. Written informed consent must be obtained.

•Hypopituitarism with or without additional pituitary hormone supplementation, a known genetic cause for I-GHD, organic GHD, ectopic posterior pituitary, other indications for GH therapy, pregnancy or lactation, any malignancy, current participation in another CTIMP, receipt of prednisolone or dexamethasone during the (minimum) 6-week discontinuation period before GH re-test

发起方

niversity College London