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

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Pegvisomant
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alberta Hospital
  • St. Joseph Health Care London
  • The Ottawa Hospital
  • McGill University Health Centre
  • Centre hospitalier universitaire de Québec-Université Laval

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pegvisomant

Arm Description

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

Outcomes

Primary Outcome Measures

Health Related Quality of Life (AcroQoL)

Secondary Outcome Measures

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

Full Information

First Posted
October 26, 2016
Last Updated
November 19, 2021
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02952885
Brief Title
Strict IGF-1 Control in Acromegaly
Acronym
I-Con
Official Title
Strict IGF-1 Control in Acromegaly (I-Con Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 27, 2017 (Actual)
Primary Completion Date
May 7, 2020 (Actual)
Study Completion Date
May 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pegvisomant
Arm Type
Experimental
Arm Description
Open-label, non-randomized single arm variable dose study of pegvisomant conducted in a real world setting.
Intervention Type
Drug
Intervention Name(s)
Pegvisomant
Other Intervention Name(s)
Somavert
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health Related Quality of Life (AcroQoL)
Time Frame
six months
Secondary Outcome Measure Information:
Title
Serum IGF-1 level
Time Frame
six months
Title
Acromegaly Disease Activity Tool (ACRODAT)
Description
To assess acromegaly co-morbidities
Time Frame
six months
Title
Patient-assessed Acromegaly Symptom Questionnaire
Description
To assess acromegaly signs and symptoms
Time Frame
six months
Title
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance Chik, MD
Organizational Affiliation
St. Michael's Hospital, Toronto, ON
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
St. Joseph Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4V2
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Centre hospitalier universitaire de Québec-Université Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Strict IGF-1 Control in Acromegaly

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