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See termination reason in detailed description.
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The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.
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 |
|---|---|---|
| Responder status at visits 9 (week 4) and 14 (week 7), where responder is defined as a patient who has achieved an IGF-1 level above the mid-point of the age-related normal range. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PD and glycemic control | At weeks 4 and 7 | |
| Change in PK concentrations. | ||
| ALT, AST greater than 3.0 times ULN at any visit |
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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 | Edegem | 2650 | Belgium | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19654233 | Derived | Touraine P, D'Souza GA, Kourides I, Abs R, Barclay P, Xie R, Pico A, Torres-Vela E, Ekman B; GH Lipoatrophy Study Group. Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH. Eur J Endocrinol. 2009 Oct;161(4):533-40. doi: 10.1530/EJE-09-0422. Epub 2009 Aug 4. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Anti-hGH and anti PHA-794428 antibody production |
| Change in body weight | At week 4 and follow-up |
| Injection site reactions |
| Ghent |
| 9000 |
| Belgium |
| Pfizer Investigational Site | Leuven | 3000 | Belgium |
| Pfizer Investigational Site | Hradec Králové | 500 05 | Czechia |
| Pfizer Investigational Site | Prague | 128 08 | Czechia |
| Pfizer Investigational Site | Aarhus C | DK-8000 | Denmark |
| Pfizer Investigational Site | Herlev | 2730 | Denmark |
| Pfizer Investigational Site | Koebenhavn OE | 2100 | Denmark |
| Pfizer Investigational Site | Odense C | DK-5000 | Denmark |
| Pfizer Investigational Site | Marseille | 13385 | France |
| Pfizer Investigational Site | Paris | 75013 | France |
| Pfizer Investigational Site | Reims | 51092 | France |
| Pfizer Investigational Site | Dresden | 01307 | Germany |
| Pfizer Investigational Site | Marburg | 35043 | Germany |
| Pfizer Investigational Site | München | 80804 | Germany |
| Pfizer Investigational Site | Messina | 98125 | Italy |
| Pfizer Investigational Site | Milan | 20122 | Italy |
| Pfizer Investigational Site | Naples | 80131 | Italy |
| Pfizer Investigational Site | Roma | 00168 | Italy |
| Pfizer Investigational Site | Torino | 10126 | Italy |
| Pfizer Investigational Site | Leiden | 2333 ZA | Netherlands |
| Pfizer Investigational Site | Lodz | 93-338 | Poland |
| Pfizer Investigational Site | Wroclaw | 50-367 | Poland |
| Pfizer Investigational Site | Ľubochňa | Slovakia | 034 91 | Slovakia |
| Pfizer Investigational Site | Bratislava | 826 06 | Slovakia |
| Pfizer Investigational Site | Alicante | Alicante | 03010 | Spain |
| Pfizer Investigational Site | Granada | Granada | 18012 | Spain |
| Pfizer Investigational Site | Santiago de Compostela | La Coruña | 15706 | Spain |
| Pfizer Investigational Site | Gothenburg | 413 45 | Sweden |
| Pfizer Investigational Site | Linköping | 581 85 | Sweden |
| Pfizer Investigational Site | Lund | 221 85 | Sweden |
| Pfizer Investigational Site | Umeå | 901 85 | Sweden |
| Pfizer Investigational Site | London | EC1A 7BE | United Kingdom |
| Pfizer Investigational Site | Manchester | M20 4BX | United Kingdom |
| Pfizer Investigational Site | Oxford | OX3 7LJ | United Kingdom |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| 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 |
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