Strict IGF-1 Control in Acromegaly

NCT02952885 | Completed Phase 3

• 1 other identifier: CCHIK-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

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.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

• Health Related Quality of Life (AcroQoL)

  six months

Secondary Outcomes (4)

• Serum IGF-1 level

  six months

• Acromegaly Disease Activity Tool (ACRODAT)

  six months

• Patient-assessed Acromegaly Symptom Questionnaire

  six months

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

  six months

Study Arms (1)

Pegvisomant

EXPERIMENTAL

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

Drug: Pegvisomant

Interventions

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.

Also known as: Somavert

Pegvisomant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (5)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

St. Joseph Health Care London

London, Ontario, N6A4V2, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Centre hospitalier universitaire de Québec-Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

MeSH Terms

Conditions

Acromegaly

Interventions

pegvisomant

Condition Hierarchy (Ancestors)

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

Study Officials

• Constance Chik, MD

  St. Michael's Hospital, Toronto, ON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 2, 2016
• Study Start: July 27, 2017
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)