Status:
COMPLETED
Tissue Biomarker for Pegvisomant Action
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Acromegaly
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Acromegaly is a disease of the pituitary gland that involves overproduction of growth hormone. Pegvisomant works by blocking binding of GH to receptors found in tissues throughout the body. Human stud...
Eligibility Criteria
Inclusion
- Diagnosis of acromegaly established on the basis of symptoms and signs at presentation, evidence of a pituitary adenoma on MRI, elevated serum concentrations of IGF1 (\>1.3 X ULN), and inadequate GH suppression (\>0.4 ng/mL) following OGTT
- Candidates to receive pegvisomant therapy following pituitary adenoma surgery, or intolerant of other medical treatments or had not undergone previous therapy
- Normal LFTs before treatment
- Dynamic testing of the pituitary axis and, if applicable, appropriate hormone replacement
Exclusion
- Treatment with a long-acting SRL within 12 weeks before enrollment
- Presence of a macroadenoma with visual field defects as a result of chiasmatic compression
- Clinically significant hepatic abnormalities and/or AST or ALT \>3 X ULN on screening
- Known hypersensitivity to any of the test materials or related compounds
- History of, or known current, problems with alcohol or drug abuse
- Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01261000
Start Date
November 1 2010
End Date
December 1 2013
Last Update
August 22 2017
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048