Canadian Pegvisomant Compassionate Study In Acromegalic Patients

Pfizer30 enrolled

Overview

The purposes of this study are: 1) to provide SOMAVERT for compassionate use to patients with acromegaly or who have completed clinical trials and were responsive, and 2) to evaluate the safety and tolerability of SOMAVERT.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acromegaly

Interventions

Pegvisomant treatmentDRUG

Medical History, demographicsPROCEDURE

Sign and symptoms: questionnairePROCEDURE

Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must have participated and completed the previous Pegvisomant studies or have shown to be unresponsive to other conventional therapies Exclusion Criteria: * ALT/AST\>3 times the ULN or have hepatic disease * have severe visual field loss, cranial nerve palsies or intracranial HTN that requires surgery to decompress the tumor * unwilling to self-administer the medication.

Locations (5)

Pfizer Investigational Site

Edmonton, Alberta, Canada

Pfizer Investigational Site

Edmonton, Alberta, Canada

Pfizer Investigational Site

Halifax, Nova Scotia, Canada

Pfizer Investigational Site

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize

Secondary Outcomes

Pegvisomant demonstrates continued safety and efficacy

Data from ClinicalTrials.gov

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