Evaluation of a treatment regimen for acromegaly

• Conditions: Acromegaly; MedDRA version: 17.0Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2010-023674-39-AT
• Lead Sponsor: Österreichisches Akromegalie Register

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-09
• Last Update Posted: 11 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. All patients with diagnosed but untreated or inadequately treated acromegaly attending the study centres
(specialized outpatient departments) in Austria will be asked to participate in this study. Patients will be included
independent of previous treatments for acromegaly including surgery and/or radiation as well as no surgery due
to patients wish or inoperability.
2. Age =18 yrs.
3. MRI of the Sellaregion not older than 6 months prior to study entry
4. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Patients on Pegvisomant at the time of inclusion
2. Previous treatment or interruption of treatment with Pegvisomant due to lack of effect
3. Known hypersensitivity or intolerance to Pegvisomant or the components of its pharmacological preparation
4. Pregnancy or lactation
5. Active liver disease (ASAT and ALAT >3x ULN)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified