Canadian Pegvisomant Compassionate Study In Acromegalic Patients
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.
1 other identifier
interventional
30
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2004
Typical duration for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedApril 24, 2008
April 1, 2008
September 7, 2005
April 22, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize
Secondary Outcomes (1)
Pegvisomant demonstrates continued safety and efficacy
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must have participated and completed the previous Pegvisomant studies or have shown to be unresponsive to other conventional therapies
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (5)
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
Related Publications (1)
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. doi: 10.25011/cim.v32i6.10662.
PMID: 20003832DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 9, 2005
Study Start
November 1, 2004
Study Completion
April 1, 2007
Last Updated
April 24, 2008
Record last verified: 2008-04