Canadian Pegvisomant Compassionate Study In Acromegalic Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

April 22, 2008

Start Date ^ICMJE

November 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00151437 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pegvisomant demonstrates continued safety and efficacy

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Canadian Pegvisomant Compassionate Study In Acromegalic Patients

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Acromegaly

Intervention ^ICMJE

Drug: Pegvisomant treatment
Procedure: Medical History, demographics
Procedure: Sign and symptoms: questionnaire
Procedure: Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT
Procedure: MRI

Study Arms / Comparison Groups

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00151437

Responsible Party

Study ID Numbers ^ICMJE

A6291017

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP