Brief Title
Strict IGF-1 Control in Acromegaly
Official Title
Strict IGF-1 Control in Acromegaly (I-Con Study)
Brief Summary
Acromegaly is a rare, chronic, and debilitating disease, usually caused by a benign tumor on the pituitary gland, which leads to excessive production of growth hormone (GH). GH excess in turn causes overproduction of another hormone called insulin-like growth factor-1 (IGF-1). IGF-1 levels are currently the most widely accepted measure of disease activity. In Canada, medical therapy with a type of medicine called "somatostatin analogues" (SSA), such as octreotide and lanreotide, is recommended for treatment of acromegaly. However, studies have shown that a significant number of patients who take SSA medications alone remain with elevated levels of IGF-1 in their blood. Another medication that is used to treat acromegaly is pegvisomant (PEGV), and the investigators plan to study whether strict control of IGF-1, by adding or optimizing the use of PEGV, results in a significant health benefits to patients who still have modestly high levels of IGF-1 in their blood.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Health Related Quality of Life (AcroQoL)
Secondary Outcome
Serum IGF-1 level
Condition
Acromegaly
Intervention
Pegvisomant
Study Arms / Comparison Groups
Pegvisomant
Description: Open-label, non-randomized single arm variable dose study of pegvisomant conducted in a real world setting.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
10
Start Date
July 27, 2017
Completion Date
May 7, 2020
Primary Completion Date
May 7, 2020
Eligibility Criteria
Inclusion Criteria: - Adult patients (at least 18 years old) with confirmed acromegaly whose IGF-I levels are persistently but modestly (1.0 ULN < [IGF-1 serum level] < 1.5 ULN) elevated following medical therapy such as SSA, PEGV, cabergoline alone or in combination. Exclusion Criteria: 1. Progressive or recent visual field loss or optic chiasmal compression, or pituitary tumors within 2mm from the chiasm. Patients whose visual field loss, optic chiasmal compression or pituitary tumor has been stable for at least a year will be eligible. 2. Cranial nerve palsies or intracranial hypertension requiring tumour decompression surgery 3. Clinically significant hepatic disease and/or elevated liver enzymes (ALT, AST > 3 x ULN) 4. Patients who have received pituitary surgery within one year prior to screening visit 5. Patients who have received radiation therapy within one year prior to screening visit 6. History of hypersensitivity to any components of Pegvisomant 7. Inability to fully comprehend the nature of the study or cooperate with study procedures 8. Pregnant / lactating women and subjects refusing to use adequate contraception to prevent pregnancy during the study. 9. Subjects unwilling or unable to self-administer medication on a daily basis 10. known or suspected alcohol / drug abuse 11. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Constance Chik, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02952885
Organization ID
CCHIK-01
Responsible Party
Sponsor
Study Sponsor
Unity Health Toronto
Study Sponsor
Constance Chik, MD, Principal Investigator, St. Michael's Hospital, Toronto, ON
Verification Date
November 2021