Canadian Pegvisomant Compassionate Study In Acromegalic Patients
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acromegaly
Intervention: Pegvisomant treatment (Drug); Medical History, demographics (Procedure); Sign and symptoms: questionnaire (Procedure); Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT (Procedure); MRI (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Patient's IGF-1 levels normalize
signs and symptoms of acromegaly normalize
Secondary outcome: Pegvisomant demonstrates continued safety and efficacy
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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:
- 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.
Locations and Contacts
Pfizer Investigational Site, Edmonton, Alberta T6G 2B7, Canada
Pfizer Investigational Site, Edmonton, Alberta T6G 2S2, Canada
Pfizer Investigational Site, Halifax, Nova Scotia B3H 2Y9, Canada
Pfizer Investigational Site, Toronto, Ontario M5G 1X5, Canada
Pfizer Investigational Site, Montreal, Quebec H2L 2W5, Canada
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting:
Starting date: November 2004
Ending date: April 2007
Last updated: April 22, 2008
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