Trial intelligence / Profile preview

Strict IGF-1 Control in Acromegaly

NCT02952885Phase 3

Key facts

Status: Completed
Start: Jul 2017
Primary completion: May 2020
Countries: 1
Sponsor: Unity Health Toronto
Modality: Recombinant Proteins and Enzymes

Drugs: pegvisomant
Conditions: acromegaly

Overview

Phase 3, open-label, single-arm trial of pegvisomant in acromegaly, sponsored by Unity Health Toronto. Primary endpoint: Health Related Quality of Life (AcroQoL) at 6 months. Started Jul 2017; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Pegvisomant
Open-label, variable dose of Pegvisomant added to or optimized within current regimen

Who it enrols

Adult patients with confirmed acromegaly and persistently elevated IGF-1 levels (1.0-1.5 ULN) despite prior medical therapy.

Endpoints

Primary

Health Related Quality of Life (AcroQoL)6 months

Secondary

Serum IGF-1 level6 months
Acromegaly Disease Activity Tool6 months
Patient-assessed Acromegaly Symptom Questionnaire6 months
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment6 months

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