Canadian Pegvisomant Compassionate Study In Acromegalic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Acromegaly

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pegvisomant treatment

Intervention Type DRUG

Medical History, demographics

Intervention Type PROCEDURE

Sign and symptoms: questionnaire

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

MRI

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No