Tissue Biomarker for Pegvisomant Action
Information source: Cedars-Sinai Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acromegaly
Intervention: Pegvisomant (Drug)
Phase: N/A
Status: Completed
Sponsored by: Cedars-Sinai Medical Center Official(s) and/or principal investigator(s):
Shlomo Melmed, MD, Principal Investigator, Affiliation: Cedars-Sinai Medical Center
Summary
Acromegaly is a disease of the pituitary gland that involves the overproduction of growth
hormone. The drug works by blocking the binding of growth hormone to growth hormone
receptors found in tissues throughout the body. Human studies have evaluated the reduction
of IGF-I levels in the blood following pegvisomant treatment, however, no studies have
evaluated IGF-I levels in tissues following pegvisomant administration. In this study, we
will test a novel tissue biomarker for pegvisomant action, distinct from measuring IGF-I
levels in the blood. To this end, we will determine if administration of pegvisomant
modifies the expression of IGF-I, IGF-I receptor, growth hormone receptor and GH- and
IGF-i-dependent signaling molecules in the colon tissue of patients with acromegaly.
Clinical Details
Official title: Tissue Biomarker for Pegvisomant Action
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Develop a tissue biomarker for pegvisomant action, other than serum IGF-I
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The subject has provided written informed consent prior to any study related
procedure
- The patient age is between 18 and 80 years inclusive
- The patient is male or female. If the woman is at risk of becoming pregnant, she must
agree to use an effective method of contraception including implants, injectables,
combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
Locations and Contacts
Cedars-Sinai Medical Center, Los Angeles, California 90048, United States
Additional Information
Starting date: November 2010
Last updated: February 2, 2015
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