Traumatic Brain InjuryEarly Phase 1NCT00929045
Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Development
A Early Phase 1 study testing Growth Hormone Replacement in people with Traumatic Brain Injury, run by University of Virginia.
Trial summary
The purpose of this study is to look at the relationship between growth hormones, and recovery from a TBI - traumatic brain injury. It is believed that a TBI may interfere with the body's ability to produce growth hormones. These hormones may be needed by the body for growth, mental development and sexual maturation. Read more about this study
- Who is it for?
- Ages 8 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Growth Hormone Replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Dec 2010
- Phase
- Early Phase 1
- 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 8 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- This is Phase II trial-subjects have already completed Phase I.
- Traumatic brain injury (TBI).
- Results of the blood work from Phase I shows that your growth hormone levels are low.
Who cannot join
- Have not completed Phase I of the study.
About this study
Official title: Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Recovery
The purpose of this study is to look at the relationship between growth hormones, and recovery from a TBI - traumatic brain injury. It is believed that a TBI may interfere with the body's ability to produce growth hormones. These hormones may be needed by the body for growth, mental development and sexual maturation.
- Conditions
- Traumatic Brain Injury
- Being tested
- Growth Hormone Replacement
- Keywords
- Growth Hormone replacement, subject 8 to 21, moderate to severe traumatic brain injury, growth hormone deficient
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth Hormone ReplacementDrug
| Study group | Role | What they receive |
|---|---|---|
| Growth Hormone | Experimental | Not described Receives: Drug: Growth Hormone Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive changes following moderate/severe TBI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJul 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Commonwealth University, National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929045
- Sponsor's protocol ID
- 13239
- Status last verified
- Dec 2023
- First submitted
- 24 Jun 2009
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone and Insulin Growth Factor 1 Deficiencies in Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Recovery
- ClinicalTrials.gov ID
- NCT00929045
- Acronym / sponsor ID
- 13239
- Conditions
- Traumatic Brain Injury
- Keywords
- Growth Hormone replacement, subject 8 to 21, moderate to severe traumatic brain injury, growth hormone deficient
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Virginia Commonwealth University, National Institutes of Health (NIH)
- Study start
- Jul 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Jun 2009 (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 look at the relationship between growth hormones, and recovery from a TBI - traumatic brain injury. It is believed that a TBI may interfere with the body's ability to produce growth hormones. These hormones may be needed by the body for growth, mental development and sexual maturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Growth Hormone | Experimental | Drug: Growth Hormone Replacement |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- This is Phase II trial-subjects have already completed Phase I.
- Traumatic brain injury (TBI).
- Results of the blood work from Phase I shows that your growth hormone levels are low.
Key exclusion criteria (1 listed)
- Have not completed Phase I of the study.
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 |
|---|---|---|
| Growth Hormone Replacement | Drug | Growth Hormone |
Primary outcome
Neurocognitive changes following moderate/severe TBI
Time frame: 1 year
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 18 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Growth Hormone Replacement in people with Traumatic Brain Injury, run by University of Virginia.
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 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 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Neurocognitive changes following moderate/severe TBI (time frame: 1 year). 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 18 Dec 2023.