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The purposes of this study are: 1) to provide SOMAVERT for compassionate use to patients with acromegaly or who have completed clinical trials and were responsive, and 2) to evaluate the safety and tolerability of SOMAVERT.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegvisomant treatment | Drug | |||
| Medical History, demographics | Procedure | |||
| Sign and symptoms: questionnaire | Procedure | |||
| Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT | Procedure | |||
| MRI | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize |
| Measure | Description | Time Frame |
|---|---|---|
| Pegvisomant demonstrates continued safety and efficacy |
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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 | Edmonton | Alberta | T6G 2B7 | Canada | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20003832 | Derived | Ezzat S, Gaspo R, Serri O, Ur E, Chik CL. A Canadian multi-centre, open-label long-term study of Pegvisomant treatment in refractory acromegaly. Clin Invest Med. 2009 Dec 1;32(6):E265. doi: 10.25011/cim.v32i6.10662. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| D055991 | Health Records, Personal |
| D003710 | Demography |
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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| Edmonton |
| Alberta |
| T6G 2S2 |
| Canada |
| Pfizer Investigational Site | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5G 1X5 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H2L 2W5 | Canada |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D008919 |
| Investigative Techniques |
| D011154 | Population Characteristics |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |