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Trial · Interventional

CompletedPhase 4Registry data

Canadian Pegvisomant Compassionate Study In Acromegalic Patients

NCTNCT00151437 (opens ClinicalTrials.gov in a new tab)Other idA6291017
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
30 participants
Sponsor
Pfizer · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

Canada

Start
Nov 2004
Primary completion
Not stated
Completion
Apr 2007
First posted
9 Sept 2005 (estimated)
Last update posted
24 Apr 2008 (estimated)
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042005200620072008
  1. Ph 4

    Canadian Pegvisomant Compassionate Study In Acromegalic Patients

    NCT00151437

    Nov 2004 to Apr 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Pegvisomant treatmentDrug
  • Medical History, demographicsProcedure
  • Sign and symptoms: questionnaireProcedure
  • Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTTProcedure
  • MRIProcedure

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(1)

  1. Pegvisomant demonstrates continued safety and efficacy

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2009

A Canadian multi-centre, open-label long-term study of Pegvisomant treatment in refractory acromegaly.

Ezzat et al. 2009Clinical and investigative medicine. Medecine clinique et experimentalecited by 7

PMID 20003832DOI 10.25011/cim.v32i6.10662PUB-20003832

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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