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.
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.
Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize
Pegvisomant demonstrates continued safety and efficacy
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
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.
18 Years - N/A
Accepts Healthy Volunteers
Pfizer CT.gov Call Center, ,
Pfizer CT.gov Call Center, Study Director, Pfizer