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Completed

NCT Number: NCT00151437

Canadian Pegvisomant Compassionate Study In Acromegalic Patients

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.

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pegvisomant treatment

Drug

Medical History, demographics

Procedure

Sign and symptoms: questionnaire

Procedure

Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT

Procedure

MRI

Procedure

Primary outcomes

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

Secondary outcomes

  1. Pegvisomant demonstrates continued safety and efficacy

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2004
Study completion
2007
First posted
Sep 9, 2005
Registry last updated
Apr 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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