AcromegalyPhase 3NCT00143416
Long Term Study With B2036-PEG
A Phase 3 study testing Pegvisomant in people with Acromegaly, run by Pfizer at 8 sites in Japan.
Trial summary
Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- Pegvisomant
- How many people
- 16 participants
- Where
- 8 sitesJapan
- Study dates
- Apr 2004to Jul 2007
- Phase
- Phase 3
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009).
Who cannot join
- Switching to other therapeutic methods for acromegaly
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Pfizer Investigational Site
Bonkyo-ku, Tokyo, 113-0022
Pfizer Investigational Site
Gakuhara, Kishiwada, Osaka, 596-8501
Pfizer Investigational Site
Hamamatsu, Shizuoka, 431-3124
Pfizer Investigational Site
Kobe, Hyogo PREF, 650-0017
Pfizer Investigational Site
Kozukue-cho, Kouhoku-ku, Yokohama-shi, Kanagawa, 222-0036
Pfizer Investigational Site
Kyoto, Kyoto, 612-8555
Pfizer Investigational Site
Sannomaru-cho, Naka-ku, Nagoya-shi, 460-0001
Pfizer Investigational Site
Shinjuku-ku, Tokyo, 162-8666
About this study
Official title: Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -
Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly.
- Conditions
- Acromegaly
- Being tested
- Pegvisomant
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegvisomantDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly
Secondary outcomes (1)
PK/PD evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startApr 2004
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT00143416
- Sponsor's protocol ID
- A6291011
- Status last verified
- Jul 2008
- First submitted
- 1 Sep 2005
- Last updated
- 29 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -
- ClinicalTrials.gov ID
- NCT00143416
- Acronym / sponsor ID
- A6291011
- Conditions
- Acromegaly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Jul 2007 (actual)
- First posted
- 2 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.
Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009).
Key exclusion criteria (1 listed)
- Switching to other therapeutic methods for acromegaly
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 | Drug | – |
Primary outcome
To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly
1 secondary outcome
PK/PD evaluation
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 29 Jul 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegvisomant in people with Acromegaly, run by Pfizer at 8 sites in Japan.
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 1 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 29 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2008.