- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02952885
Strict IGF-1 Control in Acromegaly (I-Con)
Strict IGF-1 Control in Acromegaly (I-Con Study)
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 Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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Ontario
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London, Ontario, Canada, N6A4V2
- St. Joseph Health Care London
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Ottawa, Ontario, Canada, K1H 7W9
- The Ottawa Hospital
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Quebec
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Montréal, Quebec, Canada, H4A 3J1
- McGill University Health Centre
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Quebec City, Quebec, Canada, G1V 4G2
- Centre Hospitalier Universitaire de Québec-Université Laval
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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.
- Cranial nerve palsies or intracranial hypertension requiring tumour decompression surgery
- Clinically significant hepatic disease and/or elevated liver enzymes (ALT, AST > 3 x ULN)
- Patients who have received pituitary surgery within one year prior to screening visit
- Patients who have received radiation therapy within one year prior to screening visit
- History of hypersensitivity to any components of Pegvisomant
- Inability to fully comprehend the nature of the study or cooperate with study procedures
- Pregnant / lactating women and subjects refusing to use adequate contraception to prevent pregnancy during the study.
- Subjects unwilling or unable to self-administer medication on a daily basis
- known or suspected alcohol / drug abuse
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pegvisomant
Open-label, non-randomized single arm variable dose study of pegvisomant conducted in a real world setting.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Health Related Quality of Life (AcroQoL)
Time Frame: six months
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six months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum IGF-1 level
Time Frame: six months
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six months
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Acromegaly Disease Activity Tool (ACRODAT)
Time Frame: six months
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To assess acromegaly co-morbidities
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six months
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Patient-assessed Acromegaly Symptom Questionnaire
Time Frame: six months
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To assess acromegaly signs and symptoms
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six months
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Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame: six months
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six months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Constance Chik, MD, St. Michael's Hospital, Toronto, ON
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCHIK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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