Strict IGF-1 Control in Acromegaly

Acromegaly Clinical Trial

— I-Con  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952885
• Other study ID #: CCHIK-01
• Status: Completed
• Phase: Phase 3
• Start date: July 27, 2017
• Est. completion date: May 7, 2020

Study information

• Verified date: November 2021
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 7, 2020
• Est. primary completion date: May 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acromegaly

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	St. Joseph Health Care London	London	Ontario
Canada	McGill University Health Centre	Montréal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Centre hospitalier universitaire de Québec-Université Laval	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of Life (AcroQoL)		six months
Secondary	Serum IGF-1 level		six months
Secondary	Acromegaly Disease Activity Tool (ACRODAT)	To assess acromegaly co-morbidities	six months
Secondary	Patient-assessed Acromegaly Symptom Questionnaire	To assess acromegaly signs and symptoms	six months
Secondary	Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment		six months