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Tissue Biomarker for Pegvisomant Action

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Cedars-Sinai Medical Center.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
William Gellepis, Cedars-Sinai Medical Center Identifier:
First received: December 15, 2010
Last updated: February 6, 2012
Last verified: February 2012

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.

Condition Intervention
Drug: Pegvisomant

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tissue Biomarker for Pegvisomant Action

Resource links provided by NLM:

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Develop a tissue biomarker for pegvisomant action, other than serum IGF-I [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegvisomant Drug: Pegvisomant
Pegvisomant used as indicated
Other Name: Somavert


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01261000

Contact: Billy Gellepis 310-423-3395
Contact: Lori Korsakoff, RN 310-423-2411

United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Shlomo Melmed, MD         
Sub-Investigator: Magdalena Uhart, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Principal Investigator: Shlomo Melmed, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: William Gellepis, Research Administrator, Cedars-Sinai Medical Center Identifier: NCT01261000     History of Changes
Other Study ID Numbers: 23051, WS921563
Study First Received: December 15, 2010
Last Updated: February 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases processed this record on November 25, 2014