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| Name | Class |
|---|---|
| BioPartners GmbH | INDUSTRY |
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The objective of this rollover study is to evaluate the long term (1 year) safety of a new weekly administered growth hormone preparation in adults with growth hormone deficiency who were treated with the same experimental preparation in study BPLG-005. In addition, further change in efficacy endpoints of BPLG-005 by prolonged treatment will be evaluated. Additional efficacy and safety data of the experimental preparation will be obtained from the switch-over patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LB03002 throughout | Experimental | administered LB03002 for preceding 26 weeks |
|
| Switched to LB03002 | Experimental | administered placebo for preceding 26 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth hormone - LB03002 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HJ Ji, PhD | LG Life Sciences | Study Chair |
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| ID | Term |
|---|---|
| D010900 | Pituitary Diseases |
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D004700 | Endocrine System Diseases |
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |