Growth Hormone DeficiencyPhase 2NCT00314938
A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency
A Phase 2 study testing PHA-794428 in people with Growth Hormone Deficiency, run by Pfizer at 7 sites in 5 countries.
Trial summary
This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- PHA-794428
- How many people
- 32 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Apr 2006to Nov 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1.Male and female children with a minimum age of 6 years
- 2. Prepubertal as defined by Tanner staging
- 3. Growth hormone deficiency
Who cannot join
- 1. PGHD patients with uncontrolled pituitary tumor growth
- 2. Tumors within 3 mm of the optic chiasm
- 3. Serum ALT and/or AST >= 1.5 times the upper limit of normal range
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Belgium3 sites
Pfizer Investigational Site
Brussels, 1050
Pfizer Investigational Site
Brussels, 1090
Pfizer Investigational Site
Edegem, 2650
About this study
Official title: A Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone Deficiency
This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. In addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using PK/PD modeling
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.
PK, IGF-1 and safety measurements up to 2 weeks after dosing
Secondary outcomes (1)
Antibody and IGFBP-3 measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionNov 2007
- Study completionNov 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.
- 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
- 32 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
- NCT00314938
- Sponsor's protocol ID
- A6391004
- Status last verified
- May 2011
- First submitted
- 13 Apr 2006
- Last updated
- 16 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT00314938
- Acronym / sponsor ID
- A6391004
- Conditions
- Growth Hormone Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 32 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 17 Apr 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.
This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. In addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using PK/PD modeling
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
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1.Male and female children with a minimum age of 6 years
- 2. Prepubertal as defined by Tanner staging
- 3. Growth hormone deficiency
Key exclusion criteria (3 listed)
- 1. PGHD patients with uncontrolled pituitary tumor growth
- 2. Tumors within 3 mm of the optic chiasm
- 3. Serum ALT and/or AST >= 1.5 times the upper limit of normal range
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
PK, IGF-1 and safety measurements up to 2 weeks after dosing
1 secondary outcome
Antibody and IGFBP-3 measurements
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 16 May 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Growth Hormone Deficiency
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Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
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Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Active, not recruitingObservational study
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Growth Hormone Deficiency Without Epiphyseal Closure
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
7 sites in 5 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 7 sites in 5 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 3 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 16 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 7 sites in Belgium, France, Germany, Israel, United Kingdom. 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?
PK, IGF-1 and safety measurements up to 2 weeks after dosing. 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 16 May 2011.