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Clinical Trial: Canadian Pegvisomant Compassionate Study In Acromegalic Patients
This study is currently recruiting patients.
Verified by Pfizer September 2005
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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 |
MedlinePlus related topics: Bone Diseases; Pituitary Disorders
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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 Program.
Further Study Details:
Primary Outcomes: Patient''''s IGF-1 levels normalize signs and symptoms of acromegaly normalize
Secondary Outcomes: Pegvisomant demonstrates continued safety and efficacy
Expected Total Enrollment: 30
Secondary Outcomes: Pegvisomant demonstrates continued safety and efficacy
Expected Total Enrollment: 30
Study start: November 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00151437
Kalliopi Dimos 514-693-4576 kalliopi.dimos@pfizer.com
Canada, Nova Scotia
Pfizer Investigational Site, Halifax, Nova Scotia, B3H 2Y9, Canada; Recruiting
Canada, Ontario
Pfizer Investigational Site, Toronto, Ontario, M5G 1X5, Canada; Recruiting
Canada, Quebec
Pfizer Investigational Site, Montreal, Quebec, H2L 2W5, Canada; Recruiting
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A6291017
Last Updated: September 8, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00151437
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 8, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00151437
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13
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