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Canadian Pegvisomant Compassionate Study In Acromegalic Patients

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Edmonton, Alberta, T6G 2B7 Canada
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acromegaly
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00151437
Pfizer
Completed
Canadian Pegvisomant Compassionate Study In Acromegalic Patients

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Canadian Pegvisomant Compassionate Study In Acromegalic Patients
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.
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acromegaly
  • Drug: Pegvisomant treatment
  • Procedure: Medical History, demographics
  • Procedure: Sign and symptoms: questionnaire
  • Procedure: Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT
  • Procedure: MRI
Not Provided
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2007
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00151437
A6291017
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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