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
Sponsor:
Information provided by (Responsible Party):
William Gellepis, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01261000
First received: December 15, 2010
Last updated: February 6, 2012
Last verified: February 2012
  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:


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

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261000

Contacts
Contact: Billy Gellepis 310-423-3395 Billy.Gellepis@cshs.org
Contact: Lori Korsakoff, RN 310-423-2411 lori.korsakoff@cshs.org

Locations
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
Investigators
Principal Investigator: Shlomo Melmed, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: William Gellepis, Research Administrator, 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 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Acromegaly

Additional relevant MeSH terms:
Pituitary Diseases
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014