IHR127468 - The GHD Reversal Trial
- Conditions
- Growth Hormone Deficiency (GHD)Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- CTIS2022-502008-62-00
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method