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CompletedNCT00151437Updated Apr 24, 2008

Canadian Pegvisomant Compassionate Study In Acromegalic Patients

A Phase 4 interventional study of Pegvisomant treatment and Medical History, demographics in Acromegaly, sponsored by Pfizer. Completed at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-24.

Sponsored by Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acromegaly

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03

In context

Acromegaly

203 studies on the registry are indexed under Acromegaly; 19 are open to participants now.

This study's enrollment of 30 is below the median of 43 across 116 interventional studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects must have participated and completed the previous Pegvisomant studies or have shown to be unresponsive to other conventional therapies

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants

Interventions

  • DrugPegvisomant treatment
  • ProcedureMedical History, demographics
  • ProcedureSign and symptoms: questionnaire
  • ProcedureBlood tests: IGF-1, AST/ALT/ALP/TBIL, GTT
  • ProcedureMRI
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Pegvisomant demonstrates continued safety and efficacy

07

Study locations

5 sites
  • Pfizer Investigational Site
    Edmonton, Alberta T6G 2B7, Canada
  • Pfizer Investigational Site
    Edmonton, Alberta T6G 2S2, Canada
  • Pfizer Investigational Site
    Halifax, Nova Scotia B3H 2Y9, Canada
  • Pfizer Investigational Site
    Toronto, Ontario M5G 1X5, Canada
  • Pfizer Investigational Site
    Montreal, Quebec H2L 2W5, Canada
08

References and documents

Publications

  • 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. PubMed 20003832 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00151437
Lead sponsor
Pfizer
First posted
Sep 9, 2005
Start date
Nov 2004
Completion
Apr 2007
Last update
Apr 24, 2008

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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