Strict IGF-1 Control in Acromegaly

Brief Title

Strict IGF-1 Control in Acromegaly

Official Title

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

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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Health Related Quality of Life (AcroQoL)

Secondary Outcome

 Serum IGF-1 level

Condition

Acromegaly

Intervention

Pegvisomant

Study Arms / Comparison Groups

 Pegvisomant

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

35

Start Date

July 27, 2017

Completion Date

January 31, 2021

Primary Completion Date

December 31, 2020

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Constance Chik, MD, , 

Location Countries

Canada

Location Countries

Canada

NCT ID

NCT02952885

Organization ID

CCHIK-01

Responsible Party

Principal Investigator

Study Sponsor

St. Michael's Hospital, Toronto

Study Sponsor

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

Verification Date

April 2020