Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury
NCT ID: NCT06282965
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2024-05-28
2027-09-30
Brief Summary
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The main questions this trial aims to answer are:
* Is Angiotensin (1-7) safe?
* Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI?
Participants will:
* Complete 21 days of study treatment consisting of a once-daily injection.
* Provide blood samples.
* Undergo two magnetic resonance imaging (MRI) scans of the brain.
* Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning.
Researchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ang 1-7 100 mcg/kg/day
Angiotensin I/II (1-7) acetate will be delivered as a subcutaneous injection at a dose of 100 micrograms per kilogram per day for 21 days.
Angiotensin (1-7)
The drug will be dissolved in 0.9% USP/NF grade sterile for injection saline (NaCl) and prepared in a concentration that aligns with the participant's weight.
Ang 1-7 200 mcg/kg/day
Angiotensin I/II (1-7) acetate will be delivered as a subcutaneous injection at a dose of 200 micrograms per kilogram per day for 21 days.
Angiotensin (1-7)
The drug will be dissolved in 0.9% USP/NF grade sterile for injection saline (NaCl) and prepared in a concentration that aligns with the participant's weight.
Placebo
Sterile saline (NaCl) will be delivered as a subcutaneous injection for 21 days.
Sterile saline
Sterile solution of 0.9% NaCl in water.
Interventions
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Angiotensin (1-7)
The drug will be dissolved in 0.9% USP/NF grade sterile for injection saline (NaCl) and prepared in a concentration that aligns with the participant's weight.
Sterile saline
Sterile solution of 0.9% NaCl in water.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older at time of enrollment.
* Traumatically induced head injury resulting from insult to head from an external force.
* Clinical diagnosis of acute intracranial lesion based on neuroradiologist report. CT scan and report must be available.
* Moderate or severe traumatic brain injury (TBI) defined as Glasgow Coma Scale (GCS) score on trauma presentation of 12 or less. In general: Moderate TBI will be defined as loss of consciousness between 30 minutes and 24 hours and GCS between 9 and 12. Severe TBI will be defined as loss of consciousness \> 24 hours and GCS ≤ 9.
* Enrollment within 48 hours of TBI.
Exclusion Criteria
* Neurosurgery within the last 30 days.
* History of neurodegenerative disease or disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors that would impact cognitive testing.
* Contraindication to having an MRI.
* Pregnant or lactating female.
* Female of childbearing potential or sexually active male who is not willing to use an acceptable method of birth control for the treatment period and 7 days after the last dose of the study drug.
* Participation in another clinical study involving investigational product within 30 days prior to study enrollment.
* If in the opinion of the investigator, candidate is unsuitable for participation in the study.
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Bellal Joseph, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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University of Arizona
Tucson, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Khellaf A, Khan DZ, Helmy A. Recent advances in traumatic brain injury. J Neurol. 2019 Nov;266(11):2878-2889. doi: 10.1007/s00415-019-09541-4. Epub 2019 Sep 28.
McGinn MJ, Povlishock JT. Pathophysiology of Traumatic Brain Injury. Neurosurg Clin N Am. 2016 Oct;27(4):397-407. doi: 10.1016/j.nec.2016.06.002. Epub 2016 Aug 10.
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Doobay MF, Talman LS, Obr TD, Tian X, Davisson RL, Lazartigues E. Differential expression of neuronal ACE2 in transgenic mice with overexpression of the brain renin-angiotensin system. Am J Physiol Regul Integr Comp Physiol. 2007 Jan;292(1):R373-81. doi: 10.1152/ajpregu.00292.2006. Epub 2006 Aug 31.
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Other Identifiers
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AngT-001
Identifier Type: -
Identifier Source: org_study_id
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