Growth Hormone Disorder Clinical Trial
Official title:
Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone
This study is conducted in the United States of America (USA). The aim of this observational study is to collect data concerning the treatment outcomes and safety for children and adults who are prescribed Norditropin®. Specific objectives include: 1) developing models defining the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and treatment outcomes, accounting for independent factors such as age, gender and puberty and 2) determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and other factors before treatment to clinical outcomes.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02229851 -
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
|
Phase 3 | |
| Completed |
NCT01563926 -
Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
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Phase 3 | |
| Completed |
NCT01562834 -
Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients
|
Phase 4 | |
| Completed |
NCT01109017 -
Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency
|
N/A | |
| Completed |
NCT01706783 -
A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
|
Phase 1 | |
| Completed |
NCT01245374 -
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
|
Phase 4 | |
| Completed |
NCT00184730 -
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
|
Phase 3 | |
| Completed |
NCT01502124 -
Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency
|
Phase 3 | |
| Completed |
NCT00519558 -
Growth Hormone Deficiency in Adults (GHDA)
|
Phase 3 | |
| Completed |
NCT01604161 -
Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome
|
N/A | |
| Completed |
NCT00102817 -
Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children
|
Phase 3 | |
| Terminated |
NCT01698944 -
Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency
|
Phase 4 | |
| Completed |
NCT03075644 -
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
|
Phase 3 | |
| Recruiting |
NCT02616562 -
Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
|
Phase 2 | |
| Completed |
NCT02005198 -
Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
|
N/A | |
| Completed |
NCT00567385 -
Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
|
Phase 4 | |
| Completed |
NCT03186495 -
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
|
Phase 1 | |
| Completed |
NCT00934063 -
An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®
|
N/A | |
| Completed |
NCT00715689 -
Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
|
Phase 2 | |
| Completed |
NCT00722540 -
Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
|
Phase 1 |