Canadian Pegvisomant Compassionate Study In Acromegalic Patients

This study has been completed.

First Received on September 7, 2005. Last Updated on April 22, 2008 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00151437

Purpose

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.

Condition	Intervention	Phase
Acromegaly	Drug: Pegvisomant treatment Procedure: Medical History, demographics Procedure: Sign and symptoms: questionnaire Procedure: Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT Procedure: MRI	Phase IV

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Pegvisomant demonstrates continued safety and efficacy

Estimated Enrollment:	30
Study Start Date:	November 2004
Study Completion Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151437

Locations

Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 2S2
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2L 2W5

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ezzat S, Gaspo R, Serri O, Ur E, Chik CL. A Canadian multi-centre, open-label long-term study of Pegvisomant treatment in refractory acromegaly. Clin Invest Med. 2009;32(6):E265.

ClinicalTrials.gov Identifier:	NCT00151437 History of Changes
Other Study ID Numbers:	A6291017
Study First Received:	September 7, 2005
Last Updated:	April 22, 2008
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases

Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 12, 2012