E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
isolated growth hormone deficiency after traumatic brain injury |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. To determine whether, in patients with a history of mild, moderate or severe TBI, a GHD is associated with an impairment in cardiovascular performance, a proatherogenic profile, a change in body composition (less free fat mass), a reduction in quality of life and an impairment in functional recovery. 2. To determine whether an intervention with recombinant GH has beneficial effects on the variables as mentioned under 1. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The patient visits the emergency department with mild, moderate or severe traumatic brain injury. (Mild traumatic brain injury is defined as a history of impact to the head and a Glasgow Coma Scale score (GCS) 13-15 at entry in the emergency room, moderate traumatic brain injury is defined as a GCS 9-12 at entry in the emergency room, and severe traumatic brain injury is defined as a GCS <= 8 at entry in the emergency room) 2. The trauma has occurred less than 24 hours before visiting the emergency department. 3. Age ≥ 18 years and ≤ 65 years at the time of inclusion 4. Absolute growth hormone deficiency (defined as growth hormone response < 9 mE/l in the GHRH-arginine test), diagnosed within one of the protocols going with ABR form no. 14996 or 14998 |
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E.4 | Principal exclusion criteria |
1. Age > 65 or < 18 years 2. No oral or written informed consent by patient or proxy 3. Pre-existent neuro-endocrine disorder 4. Co-existent dysfunction of pituitary axis other than the somatotropic axis 5. Instable infiltrative disease in the hypothalamus/pituitary region (eg sarcoidosis, tumour metastasis) 6. BMI >30 kg/m2 7. Primary dyslipidemia that necessitates treatment 8. Positive family history of premature cardiovascular disease 9. Overt diabetes mellitus type II (including a history of gestational diabetes mellitus) 10. Impairment in renal function (Creatinin clearance < 60 ml/min) 11. Pregnancy or wish for pregnancy during the study period, lactation 12. Retinal disease 13. Co-existent disease with decreased life expectancy, especially active malignant tumor 14. Chronic alcohol or drug abuse |
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E.5 End points |
E.5.1 | Primary end point(s) |
1.Change in different components of the GHD syndrome (anthropometric characteristics, cardiovascular performance and risk profile, cognitive function and QoL), before and after GH substitution, in patients with TBI 2.Change in physical and neuro-cognitive factors such as Glasgow Outcome Score-extended version, not necessarily associated with GHD syndrome, before and after GH substitution, in patients with TBI
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
off-on-off treatment, self-controlled |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |