Skip to content

Trial · Interventional

CompletedPhase 3Registry data

Strict IGF-1 Control in Acromegaly

Short name I-Con

NCTNCT02952885 (opens ClinicalTrials.gov in a new tab)Other idCCHIK-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
10 participants (actual)
Sponsor
Unity Health Toronto · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Canada

Start
27 Jul 2017
Primary completion
7 May 2020
Completion
7 May 2020
First posted
2 Nov 2016 (estimated)
Last update posted
22 Nov 2021
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018201920202021
  1. Ph 3

    I-Con

    NCT02952885

    27 Jul 2017 to 7 May 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PegvisomantDrug

Arms1

  • Experimental

    Pegvisomant

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Health Related Quality of Life (AcroQoL)

    Time frame · six months

Secondary outcomes(4)

  1. Serum IGF-1 level

    Time frame · six months

  2. Acromegaly Disease Activity Tool (ACRODAT)

    Time frame · six months

    Registry description

    To assess acromegaly co-morbidities

  3. Patient-assessed Acromegaly Symptom Questionnaire

    Time frame · six months

    Registry description

    To assess acromegaly signs and symptoms

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

    Time frame · six months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.