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See termination reason in detailed description.
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This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. In addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using PK/PD modeling
The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHA-794428 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| PK, IGF-1 and safety measurements up to 2 weeks after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody and IGFBP-3 measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brussels | 1050 | Belgium | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Brussels |
| 1090 |
| Belgium |
| Pfizer Investigational Site | Edegem | 2650 | Belgium |
| Pfizer Investigational Site | Paris | 75019 | France |
| Pfizer Investigational Site | Erlangen | 91054 | Germany |
| Pfizer Investigational Site | Petah Tikva | Israel | 49202 | Israel |
| Pfizer Investigational Site | Cardiff | CF14 4XN | United Kingdom |
| D001849 |
| Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |