Canadian Pegvisomant Compassionate Study In Acromegalic Patients

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00151437

First received: September 7, 2005

Last updated: April 22, 2008

Last verified: April 2008

History of Changes

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 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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.

Resource links provided by NLM:

Drug Information available for: Pegvisomant

Genetic and Rare Diseases Information Center resources: Acromegaly

U.S. FDA Resources

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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 Dec 1;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

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 August 16, 2017

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