Canadian Pegvisomant Compassionate Study In Acromegalic Patients
Phase 4
Completed
- Conditions
- Acromegaly
- Registration Number
- NCT00151437
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize
- Secondary Outcome Measures
Name Time Method Pegvisomant demonstrates continued safety and efficacy
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇦Montreal, Quebec, Canada