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NCT00151437 Clinical Trial

Canadian Pegvisomant Compassionate Study In Acromegalic Patients

Acromegaly Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00151437
Other study ID # A6291017
Secondary ID
Status Completed
Phase Phase 4
First received September 7, 2005
Last updated April 22, 2008
Start date November 2004
Est. completion date April 2007

Study information
Verified date April 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pegvisomant treatment

Procedure:
• Medical History, demographics

• Sign and symptoms: questionnaire

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

• MRI

Locations
Country Name City State
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize
Secondary Pegvisomant demonstrates continued safety and efficacy
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Recruiting NCT04520646 - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy N/A
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