Canadian Pegvisomant Compassionate Study In Acromegalic Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00151437 |
Recruitment Status :
Completed
First Posted : September 9, 2005
Last Update Posted : April 24, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
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 | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | November 2004 |
Actual Study Completion Date : | April 2007 |

- Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize
- Pegvisomant demonstrates continued safety and efficacy

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151437
Canada, Alberta | |
Pfizer Investigational Site | |
Edmonton, Alberta, Canada, T6G 2B7 | |
Pfizer Investigational Site | |
Edmonton, Alberta, Canada, T6G 2S2 | |
Canada, Nova Scotia | |
Pfizer Investigational Site | |
Halifax, Nova Scotia, Canada, B3H 2Y9 | |
Canada, Ontario | |
Pfizer Investigational Site | |
Toronto, Ontario, Canada, M5G 1X5 | |
Canada, Quebec | |
Pfizer Investigational Site | |
Montreal, Quebec, Canada, H2L 2W5 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00151437 |
Other Study ID Numbers: |
A6291017 |
First Posted: | September 9, 2005 Key Record Dates |
Last Update Posted: | April 24, 2008 |
Last Verified: | April 2008 |
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases |