drugset / Trial / NCT02952885

Strict IGF-1 Control in Acromegaly

NCT02952885

Phase 3 Completed 10 enrolled Unity Health Toronto
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-07-27
Primary completion
2020-05-07
Completion
2020-05-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegvisomant Protein / enzyme biologic 5 mg
Subject Pegvisomant Protein / enzyme biologic 10 mg
Subject Pegvisomant Protein / enzyme biologic 20 mg
Subject Pegvisomant Protein / enzyme biologic 40 mg

Indications