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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019980-13 | EudraCT Number |
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Participant enrollment was not feasible
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The evaluation of a standardized diagnostic test to predict the growth response in a 1 year trial with Growth Hormone (GH) treatment (carried out in the context of regular patient care) in non GH deficient short children with low serum insulin-like growth factor-1 (IGF-1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NutropinAq | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutropin [Somatropin (rDNA origin) for injection] | Drug | Doses in the diagnostic protocol are 0.7 and 1.4 mg/m2/day, injected by subcutaneous injection at bedtime for 2 weeks, divided by washout periods of preferably 4 weeks (accepted range 4-6 weeks). An additional period of 2 weeks on 2.8 mg/m2/day (after a washout period of 4-6 weeks) will be added if the IGF-I response on either dosage is insufficient (serum IGF-I SDS <0). |
| Measure | Description | Time Frame |
|---|---|---|
| Peak serum IGF-1 level with GH (1.4 mg/m2/day) change from baseline. | Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Delta IGF-1 SDS on 0.7 & 1.4 mg GH/m2/day | Baseline, week 2 | |
| Delta insulin-like growth factor binding protein-3 (IGFBP-3) standard deviation score (SDS) on 0.7 & 1.4 mg GH/m2/day | Baseline, week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director, MD | Ipsen | Study Director |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| D000074584 | WW Domain-Containing Oxidoreductase |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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|
| Delta of the ratio IGF-1:IGFBP-3 SDS on 0.7 mg & 1.4 mg GH/m2/day | Baseline, week 2 |
| Delta of the ratio IGF-1:IGFBP-2 (insulin-like growth factor binding protein-2) SDS on 0.7 mg & 1.4 mg GH/m2/day | Baseline, week 2 |
| Peak IGFBP-3 SDS on 0.7 mg & 1.4 mg GH/m2/day | Baseline, week 2 |
| Peak of the ratio IGF-1:IGFBP-3 SDS on 0.7 mg & 1.4 mg GH/m2/day | Baseline, week 2 |
| Peak of the ratio IGF-1:IGFBP-2 SDS on 0.7 mg & 1.4 mg GH/m2/day | Baseline, week 2 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000074583 | Short Chain Dehydrogenase-Reductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |