Strict IGF-1 Control in Acromegaly

NCT ID: NCT02952885

Last Updated: 2021-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-27
• Study Completion Date: 2020-05-07

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.

Conditions

Acromegaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegvisomant

Open-label, non-randomized single arm variable dose study of pegvisomant conducted in a real world setting.

Group Type: EXPERIMENTAL

Pegvisomant

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Somavert

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Constance Chik, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, Toronto, ON

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

St. Joseph Health Care London

London, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Centre hospitalier universitaire de Québec-Université Laval

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

CCHIK-01

Identifier Type: -

Identifier Source: org_study_id