AcromegalyPhase 4NCT00151437
Canadian Pegvisomant Compassionate Study In Acromegalic Patients
A Phase 4 study testing Pegvisomant treatment, Medical History, demographics and Sign and symptoms: questionnaire in people with Acromegaly, run by Pfizer at 5 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Pegvisomant treatment, Medical History, demographics and Sign and symptoms: questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 5 sitesCanada
- Study dates
- Nov 2004to Apr 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have participated and completed the previous Pegvisomant studies or have shown to be unresponsive to other conventional therapies
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Pfizer Investigational Site
Edmonton, Alberta, T6G 2B7
Pfizer Investigational Site
Edmonton, Alberta, T6G 2S2
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Pfizer Investigational Site
Montreal, Quebec, H2L 2W5
Pfizer Investigational Site
Toronto, Ontario, M5G 1X5
About this study
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.
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.
- Conditions
- Acromegaly
- Being tested
- Pegvisomant treatment, Medical History, demographics, Sign and symptoms: questionnaire, Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT, MRI
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegvisomant treatmentDrug
Medical History, demographicsProcedure or surgery
Sign and symptoms: questionnaireProcedure or surgery
Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTTProcedure or surgery
MRIProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize
Secondary outcomes (1)
Pegvisomant demonstrates continued safety and efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startNov 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151437
- Sponsor's protocol ID
- A6291017
- Status last verified
- Apr 2008
- First submitted
- 7 Sep 2005
- Last updated
- 24 Apr 2008
- Results posted
- No
Publications
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. doi: 10.25011/cim.v32i6.10662.
PubMed 20003832
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00151437
- Acronym / sponsor ID
- A6291017
- Conditions
- Acromegaly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must have participated and completed the previous Pegvisomant studies or have shown to be unresponsive to other conventional therapies
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegvisomant treatment | Drug | – |
| Medical History, demographics | Procedure or surgery | – |
| Sign and symptoms: questionnaire | Procedure or surgery | – |
| Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT | Procedure or surgery | – |
| MRI | Procedure or surgery | – |
Primary outcome
Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize
1 secondary outcome
Pegvisomant demonstrates continued safety and efficacy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2008.
- Derived from this study: PubMed 20003832Ezzat 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. doi: 10.25011/cim.v32i6.10662.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegvisomant treatment, Medical History, demographics and Sign and symptoms: questionnaire in people with Acromegaly, run by Pfizer at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00151437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2008.