Canadian Pegvisomant Compassionate Study In Acromegalic Patients

A Multi-Center, Open-Label Study For The Compassionate Use Of Pegvisomant In Acromegalic Patients Refractory To Conventional Therapy and For Patients Who Received The Product During The Clinical Development Program.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151437

Enrollment

Registered

2005-09-09

Start date

2004-11-30

Completion date

2007-04-30

Last updated

2008-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Brief summary

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.

Interventions

DRUGPegvisomant treatment

PROCEDUREMedical History, demographics

PROCEDURESign and symptoms: questionnaire

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

PROCEDUREMRI

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize	—

Secondary

Measure	Time frame
Pegvisomant demonstrates continued safety and efficacy	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026