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

November 19, 2021 updated by: Unity Health Toronto

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • Ontario
      • London, Ontario, Canada, N6A4V2
        • St. Joseph Health Care London
      • Ottawa, Ontario, Canada, K1H 7W9
        • The Ottawa Hospital
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
      • Quebec City, Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Québec-Université Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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:
  • Somavert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health Related Quality of Life (AcroQoL)
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum IGF-1 level
Time Frame: six months
six months
Acromegaly Disease Activity Tool (ACRODAT)
Time Frame: six months
To assess acromegaly co-morbidities
six months
Patient-assessed Acromegaly Symptom Questionnaire
Time Frame: six months
To assess acromegaly signs and symptoms
six months
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Constance Chik, MD, St. Michael's Hospital, Toronto, ON

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2017

Primary Completion (Actual)

May 7, 2020

Study Completion (Actual)

May 7, 2020

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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