Brief Title
Canadian Pegvisomant Compassionate Study In Acromegalic Patients
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.
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize
Secondary Outcome
Pegvisomant demonstrates continued safety and efficacy
Condition
Acromegaly
Intervention
Pegvisomant treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
November 2004
Completion Date
April 2007
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00151437
Organization ID
A6291017
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
April 2008