A prospective, multi-centre, phase IV study to evaluate safety and efficacy of SomatoRelTM (recombinant human growth hormone manufactured by Reliance Life Sciences Pvt. Ltd.) in growth hormone deficient children

Reliance Life Sciences Pvt Ltd RLS0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

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•1. Pre-pubertal males less than 11 years of age and females less than 12 years of age.
•2. Patients with diagnosis of growth failure due to idiopathic growth hormone deficiency confirmed during the screening by a standard GH stimulation test
•3. Parents/guardian willing to give informed consent and patient willing to give assent (verbal or written) for the study as defined below:
•- For children <7 years of age there is no need for written assent from the participant. However, verbal assent should be obtained in the presence of the parents/guardian.
•- For children =7 and <12 years, verbal assent must be obtained in the presence of the parents/guardian and should be recorded by the parents/guardian.

•1. Patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure.
•2. Patients with active malignancy or intracranial tumor.
•3. Patients with closed epiphyses.
•4. Patients with Prader-Willi syndrome.
•5. Patients with a known hypersensitivity to SomatoRelTM or any of its excipients.
•6. Growth retardation attributable to causes other than GHD (e.g. inborn errors of metabolism, primary bone disease, chromosomal disorders, etc.)
•7. History of clinically significant diseases, e.g. progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic or cerebral disease that renders the patient incapable of participating in the study.
•8. Patient participation in another clinical trial 30 days prior to SomatoRelTM administration.
•9. Any other condition which investigator feels would pose a significant hazard to the patient, if SomatoRelTM is administered.

发起方

Reliance Life Sciences Pvt Ltd RLS