Canadian Pegvisomant Compassionate Study In Acromegalic Patients

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

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.