AcromegalyPhase 3I-ConNCT02952885
Strict IGF-1 Control in Acromegaly
A Phase 3 study testing Pegvisomant in people with Acromegaly, run by Unity Health Toronto at 5 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Pegvisomant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesCanada
- Study dates
- 27 Jul 2017to 7 May 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
St. Joseph Health Care London
London, Ontario, N6A4V2
McGill University Health Centre
Montreal, Quebec, H4A 3J1
The Ottawa Hospital
Ottawa, Ontario, K1H 7W9
Centre hospitalier universitaire de Québec-Université Laval
Québec, Quebec, G1V 4G2
About this study
Official title: Strict IGF-1 Control in Acromegaly (I-Con Study)
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.
- Conditions
- Acromegaly
- Being tested
- Pegvisomant
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegvisomantDrug
Also called Somavert
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.
| Study group | Role | What they receive |
|---|---|---|
| Pegvisomant | Experimental | Open-label, non-randomized single arm variable dose study of pegvisomant conducted in a real world setting. Receives: Drug: Pegvisomant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life (AcroQoL)
Measured: six months
Secondary outcomes (4)
Serum IGF-1 level
Measured: six months
Acromegaly Disease Activity Tool (ACRODAT)
To assess acromegaly co-morbidities
Measured: six months
Patient-assessed Acromegaly Symptom Questionnaire
To assess acromegaly signs and symptoms
Measured: six months
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start27 Jul 2017
- Primary completion7 May 2020
- Study completion7 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Constance Chik, MD, Principal investigator, St. Michael's Hospital, Toronto, ON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952885
- Sponsor's protocol ID
- CCHIK-01
- Acronym
- I-Con
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2016
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strict IGF-1 Control in Acromegaly (I-Con Study)
- ClinicalTrials.gov ID
- NCT02952885
- Acronym / sponsor ID
- I-Con / CCHIK-01
- Conditions
- Acromegaly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegvisomant | Experimental | Drug: PegvisomantOpen-label, non-randomized single arm variable dose study of pegvisomant conducted in a real world setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegvisomantAlso: SomavertStudy 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. | Drug | Pegvisomant |
Primary outcome
Health Related Quality of Life (AcroQoL)
Time frame: six months
4 secondary outcomes
Serum IGF-1 level
Time frame: six months
Acromegaly Disease Activity Tool (ACRODAT)
Time frame: six months
Patient-assessed Acromegaly Symptom Questionnaire
Time frame: six months
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Acromegaly
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RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constance Chik, MD principal investigator
St. Michael's Hospital, Toronto, ON
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegvisomant in people with Acromegaly, run by Unity Health Toronto at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (AcroQoL) (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.