Growth Hormone DeficiencyPhase 2NCT00308464
A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency
A Phase 2 study testing PHA-794428 in people with Growth Hormone Deficiency, run by Pfizer at 35 sites in 12 countries.
Trial summary
The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- PHA-794428
- How many people
- 136 participants
- Where
- 35 sitesin 12 countries
- Study dates
- Jul 2006to Dec 2007
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with severe AGHD.
- Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months.
Who cannot join
- AGHD patients with uncontrolled pituitary tumor growth.
- Tumors within 3 mm of the optic chiasm.
- Patients with diabetes mellitus.
Trial locations and contacts
35 sites in 12 countries.
35 sites in 12 countries
Italy5 sites
Pfizer Investigational Site
Messina, 98125
Pfizer Investigational Site
Milan, 20122
Pfizer Investigational Site
Naples, 80131
Pfizer Investigational Site
Roma, 00168
Pfizer Investigational Site
Torino, 10126
Denmark4 sites
Pfizer Investigational Site
Aarhus C, DK-8000
Pfizer Investigational Site
Herlev, 2730
Pfizer Investigational Site
Koebenhavn OE, 2100
Pfizer Investigational Site
Odense C, DK-5000
Sweden4 sites
Pfizer Investigational Site
Gothenburg, 413 45
Pfizer Investigational Site
Linköping, 581 85
Pfizer Investigational Site
Lund, 221 85
Pfizer Investigational Site
Umeå, 901 85
Belgium3 sites
Pfizer Investigational Site
Edegem, 2650
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Leuven, 3000
France3 sites
Pfizer Investigational Site
Marseille, 13385
Pfizer Investigational Site
Paris, 75013
Pfizer Investigational Site
Reims, 51092
Germany3 sites
Pfizer Investigational Site
Dresden, 01307
Pfizer Investigational Site
Marburg, 35043
Pfizer Investigational Site
München, 80804
Spain3 sites
Pfizer Investigational Site
Alicante, Alicante, 03010
Pfizer Investigational Site
Granada, Granada, 18012
Pfizer Investigational Site
Santiago de Compostela, La Coruña, 15706
United Kingdom3 sites
Pfizer Investigational Site
London, EC1A 7BE
Pfizer Investigational Site
Manchester, M20 4BX
Pfizer Investigational Site
Oxford, OX3 7LJ
Czechia2 sites
Pfizer Investigational Site
Hradec Králové, 500 05
Pfizer Investigational Site
Prague, 128 08
Poland2 sites
Pfizer Investigational Site
Lodz, 93-338
Pfizer Investigational Site
Wroclaw, 50-367
Slovakia2 sites
Pfizer Investigational Site
Bratislava, 826 06
Pfizer Investigational Site
Ľubochňa, Slovakia, 034 91
About this study
Official title: A Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient Patients
The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.
Read the detailed description
The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.
- Conditions
- Growth Hormone Deficiency
- Being tested
- PHA-794428
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHA-794428Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder status at visits 9 (week 4) and 14 (week 7), where responder is defined as a patient who has achieved an IGF-1 level above the mid-point of the age-related normal range.
Secondary outcomes (6)
Change in PD and glycemic control
Measured: At weeks 4 and 7
Change in PK concentrations.
ALT, AST greater than 3.0 times ULN at any visit
Anti-hGH and anti PHA-794428 antibody production
Change in body weight
Measured: At week 4 and follow-up
Injection site reactions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: See termination reason in detailed description.
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 Growth Hormone DeficiencyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 136 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
- NCT00308464
- Sponsor's protocol ID
- A6391003
- Status last verified
- May 2011
- First submitted
- 27 Mar 2006
- Last updated
- 18 May 2011
- Results posted
- No
Publications
Touraine P, D'Souza GA, Kourides I, Abs R, Barclay P, Xie R, Pico A, Torres-Vela E, Ekman B; GH Lipoatrophy Study Group. Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH. Eur J Endocrinol. 2009 Oct;161(4):533-40. doi: 10.1530/EJE-09-0422. Epub 2009 Aug 4.
PubMed 19654233
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient Patients
- ClinicalTrials.gov ID
- NCT00308464
- Acronym / sponsor ID
- A6391003
- Conditions
- Growth Hormone Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 136 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 29 Mar 2006 (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 purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.
Detailed description
The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients with severe AGHD.
- Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months.
Key exclusion criteria (3 listed)
- AGHD patients with uncontrolled pituitary tumor growth.
- Tumors within 3 mm of the optic chiasm.
- Patients with diabetes mellitus.
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 |
|---|---|---|
| PHA-794428 | Drug | – |
Primary outcome
Responder status at visits 9 (week 4) and 14 (week 7), where responder is defined as a patient who has achieved an IGF-1 level above the mid-point of the age-related normal range.
6 secondary outcomes
Change in PD and glycemic control
Time frame: At weeks 4 and 7
Change in PK concentrations.
ALT, AST greater than 3.0 times ULN at any visit
Anti-hGH and anti PHA-794428 antibody production
Change in body weight
Time frame: At week 4 and follow-up
Injection site reactions
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
- Derived from this study: PubMed 19654233Touraine P, D'Souza GA, Kourides I, Abs R, Barclay P, Xie R, Pico A, Torres-Vela E, Ekman B; GH Lipoatrophy Study Group. Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH. Eur J Endocrinol. 2009 Oct;161(4):533-40. doi: 10.1530/EJE-09-0422. Epub 2009 Aug 4.
- 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
35 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PHA-794428 in people with Growth Hormone Deficiency, run by Pfizer at 35 sites in 12 countries.
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 2 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: stopped early, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Italy, Denmark, Sweden, Belgium, France and 7 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
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?
Responder status at visits 9 (week 4) and 14 (week 7), where responder is defined as a patient who has achieved an IGF-1 level above the mid-point of the age-related normal range.. 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 NCT00308464, 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 18 May 2011; AzTrials last refreshed its copy on 31 Oct 2026.