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I-Con: Strict IGF-1 Control in Acromegaly

Sponsor
Unity Health Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT02952885
Collaborator
(none)
10
Enrollment
5
Locations
1
Arm
33.3
Actual Duration (Months)
2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Strict IGF-1 Control in Acromegaly (I-Con Study)
Actual Study Start Date :
Jul 27, 2017
Actual Primary Completion Date :
May 7, 2020
Actual Study Completion Date :
May 7, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pegvisomant

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

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.
Other Names:
  • Somavert

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Health Related Quality of Life (AcroQoL) [six months]

    Secondary Outcome Measures

    1. Serum IGF-1 level [six months]

    2. Acromegaly Disease Activity Tool (ACRODAT) [six months]

      To assess acromegaly co-morbidities

    3. Patient-assessed Acromegaly Symptom Questionnaire [six months]

      To assess acromegaly signs and symptoms

    4. Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [six months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
    2 St. Joseph Health Care London London Ontario Canada N6A4V2
    3 The Ottawa Hospital Ottawa Ontario Canada K1H 7W9
    4 McGill University Health Centre Montréal Quebec Canada H4A 3J1
    5 Centre hospitalier universitaire de Québec-Université Laval Quebec City Quebec Canada G1V 4G2

    Sponsors and Collaborators

    • Unity Health Toronto

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Unity Health Toronto
    ClinicalTrials.gov Identifier:
    NCT02952885
    Other Study ID Numbers:
    • CCHIK-01
    First Posted:
    Nov 2, 2016
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acromegaly

    Study Results

    No Results Posted as of Nov 22, 2021