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Tissue Biomarker for Pegvisomant Action

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shlomo Melmed, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01261000
First received: December 15, 2010
Last updated: February 2, 2015
Last verified: February 2015
History of Changes
  Purpose

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
Acromegaly
 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:

Drug Information available for: Pegvisomant
U.S. FDA Resources

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 ]
Enrollment: 8
Study Start Date: November 2010
Study Completion Date: December 2013
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

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT01261000

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Shlomo Melmed, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Shlomo Melmed, MD, Senior Vice President, Academic Affairs, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01261000     History of Changes
Other Study ID Numbers: 23051, WS921563
Study First Received: December 15, 2010
Last Updated: February 2, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Acromegaly

ClinicalTrials.gov processed this record on March 03, 2015