NCT02952885

Strict IGF-1 Control in Acromegaly

Strict IGF-1 Control in Acromegaly (I-Con Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Pegvisomant	Study medications will be prescribed as per clinical practice with PEGV being added, or optimally dosed, at the Month 0 visit. Subjects who are naïve to PEGV should start their injections from 10 mg twice a week to 10 mg daily if used as combination therapy or 10 to 20 mg daily if used as monotherapy. Maximum dosing should not exceed 40mg/day. Dosing of PEGV can be adjusted as per clinical judgement to meet the normalization of IGF-1 levels (\<1.0 ULN) in increments of 5-10mg/day. In the event of a reduction in IGF-1 below the LLN, the dose of PEGV could be decreased by 5-10 mg/day.

Timeline

• Start date: 2017-07-27
• Primary completion: 2020-05-07
• Completion: 2020-05-07
• First posted: 2016-11-02
• Last updated: 2021-11-22

Locations

5 sites across 1 country: Canada