search
Back to results

Canadian Pegvisomant Compassionate Study In Acromegalic Patients

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Pegvisomant treatment
Medical History, demographics
Sign and symptoms: questionnaire
Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT
MRI
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pegvisomant demonstrates continued safety and efficacy

Full Information

First Posted
September 7, 2005
Last Updated
April 22, 2008
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00151437
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pegvisomant treatment
Intervention Type
Procedure
Intervention Name(s)
Medical History, demographics
Intervention Type
Procedure
Intervention Name(s)
Sign and symptoms: questionnaire
Intervention Type
Procedure
Intervention Name(s)
Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT
Intervention Type
Procedure
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize
Secondary Outcome Measure Information:
Title
Pegvisomant demonstrates continued safety and efficacy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2S2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 2W5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20003832
Citation
Ezzat S, Gaspo R, Serri O, Ur E, Chik CL. A Canadian multi-centre, open-label long-term study of Pegvisomant treatment in refractory acromegaly. Clin Invest Med. 2009 Dec 1;32(6):E265. doi: 10.25011/cim.v32i6.10662.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6291017&StudyName=Canadian%20Pegvisomant%20Compassionate%20Study%20In%20Acromegalic%20Patients%20
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Canadian Pegvisomant Compassionate Study In Acromegalic Patients

We'll reach out to this number within 24 hrs