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NCT01261000 Clinical Trial

Tissue Biomarker for Pegvisomant Action

Acromegaly Clinical Trial

Official title:
Tissue Biomarker for Pegvisomant Action

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01261000
Other study ID # 23051
Secondary ID WS921563
Status Completed
Phase N/A
First received December 15, 2010
Last updated February 2, 2015
Start date November 2010
Est. completion date December 2013

Study information
Verified date February 2015
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date December 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pegvisomant
Pegvisomant used as indicated

Locations
Country Name City State
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Develop a tissue biomarker for pegvisomant action, other than serum IGF-I 1 year No
See also
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Completed NCT02012127 - Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
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Completed NCT00531908 - Physiopathology of Sodium Retention in Acromegaly N/A
Completed NCT00500227 - Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
Completed NCT01278342 - Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Phase 4
Active, not recruiting NCT01809808 - A Prospective Study of Outcome After Therapy for Acromegaly
Completed NCT00145405 - Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction Phase 4
Completed NCT00210457 - Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Phase 3
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Recruiting NCT00005100 - Measurement of Outcome of Surgical Treatment in Patients With Acromegaly N/A
Completed NCT00521300 - Preoperative Octreotide Treatment of Acromegaly Phase 4
Completed NCT03548415 - Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands Phase 2
Not yet recruiting NCT04066569 - Reproducibility and Utility of OGTT in Acromegaly N/A
Not yet recruiting NCT05298891 - Hypoproteic Diet in Acromegaly N/A
Recruiting NCT04520646 - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy N/A
Not yet recruiting NCT04529356 - The TMS Treatment for Postoperative Headache in GH Tumor N/A
Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3