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

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ClinicalTrials.gov Identifier: NCT02952885
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Constance Chik, St. Michael's Hospital, Toronto

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
Acromegaly Drug: Pegvisomant Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
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 : July 27, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020


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 Name: Somavert




Primary Outcome Measures :
  1. Health Related Quality of Life (AcroQoL) [ Time Frame: six months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952885


Contacts
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Contact: Dominic Lee 416-864-6060 ext 77058 leekih@smh.ca
Contact: Judith Hall 416-864-6060 ext 7121 hallju@smh.ca

Locations
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Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Stephen Culver, RN    780-407-6135    Stephen.Culver@albertahealthservices.ca   
Principal Investigator: Constance Chik, MD, PhD         
Canada, Ontario
St. Joseph Health Care London Recruiting
London, Ontario, Canada, N6A4V2
Contact: Sarah De Brabandere    519-685-8500 ext 56399    sarah.debrabandere@lhsc.on.ca   
Principal Investigator: Stan Van Uum, MD         
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 7W9
Contact: Denise DeCurtis    613-738-8400 ext 81961    ddecurtis@toh.ca   
Principal Investigator: Heather Lochnan, MD         
Canada, Quebec
McGill University Health Centre Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Laya Fayyazi    514-934-1934 ext 35378    Laya.Fayyazi@MUHC.MCGILL.CA   
Principal Investigator: Juan Andres Rivera Ramirez, MD         
Centre hospitalier universitaire de Québec-Université Laval Recruiting
Quebec City, Quebec, Canada, G1V 4G2
Contact: Marie-Christine Dubé    418-525-4444 ext 47904    Marie-Christine.Dube@crchudequebec.ulaval.ca   
Principal Investigator: Marie-Claire Denis, MD         
Sub-Investigator: Marie-Ève Domingue, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Constance Chik, MD St. Michael's Hospital, Toronto, ON

Publications:

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Responsible Party: Constance Chik, Affiliate Scientist, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02952885     History of Changes
Other Study ID Numbers: CCHIK-01
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases