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Canadian Pegvisomant Compassionate Study In Acromegalic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00151437
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : April 24, 2008
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : November 2004
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Pegvisomant

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize

Secondary Outcome Measures :
  1. Pegvisomant demonstrates continued safety and efficacy

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151437


Locations
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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
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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

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ClinicalTrials.gov Identifier: NCT00151437    
Other Study ID Numbers: A6291017
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: April 24, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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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