Tissue Biomarker for Pegvisomant Action
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ClinicalTrials.gov Identifier: NCT01261000 |
Recruitment Status
:
Completed
First Posted
: December 16, 2010
Results First Posted
: August 22, 2017
Last Update Posted
: August 22, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acromegaly | Drug: Pegvisomant | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Tissue Biomarker for Pegvisomant Action |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Pegvisomant |
Drug: Pegvisomant
Pegvisomant used as indicated
Other Name: Somavert
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- Effect of Pegvisomant on Colon Tissue p53 Expression [ Time Frame: 8 weeks ]Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261000
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 |
Principal Investigator: | Shlomo Melmed, MD | Cedars-Sinai Medical Center |
Publications:
Responsible Party: | Shlomo Melmed, MD, Executive Vice President, Academic Affairs, Cedars-Sinai Medical Center |
ClinicalTrials.gov Identifier: | NCT01261000 History of Changes |
Other Study ID Numbers: |
Pro23051 WS921563 ( Other Grant/Funding Number: Pfizer ) |
First Posted: | December 16, 2010 Key Record Dates |
Results First Posted: | August 22, 2017 |
Last Update Posted: | August 22, 2017 |
Last Verified: | July 2017 |
Keywords provided by Shlomo Melmed, MD, Cedars-Sinai Medical Center:
Acromegaly |
Additional relevant MeSH terms:
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases |