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NCT Number: NCT02952885

Strict IGF-1 Control in Acromegaly

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.

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pegvisomant

Drug

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

Primary outcomes

  1. Health Related Quality of Life (AcroQoL)

    Time frame: six months

Secondary outcomes

  1. Serum IGF-1 level

    Time frame: six months

  2. Acromegaly Disease Activity Tool (ACRODAT)

    Time frame: six months

    To assess acromegaly co-morbidities

  3. Patient-assessed Acromegaly Symptom Questionnaire

    Time frame: 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

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Acronym: I-Con

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 2, 2016
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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