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Peptide

Angiotensin (1-7) for Traumatic Brain Injury (ANGel T Trial)

Phase 1 & 2
Recruiting
Led By Bellal Joseph, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Age 18 years or older at time of enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to 21 days, enrollment to 90 days
Awards & highlights

Summary

This trial aims to test the safety and effectiveness of the drug Angiotensin (1-7) in treating people with moderate to severe traumatic brain injury (TBI). Participants will receive a once

Who is the study for?
This trial is for adults who've had a moderate to severe traumatic brain injury (TBI) with a Glasgow Coma Scale score of 12 or less. They must be enrolled within 48 hours of the injury and have a CT scan confirming an acute intracranial lesion. Consent from the participant or representative is required.
What is being tested?
The trial tests Angiotensin (1-7)'s safety and effectiveness in improving mental function and reducing physical signs of TBI damage. It involves daily injections for 21 days, blood samples, two MRI scans, tasks, and questionnaires to assess brain function.
What are the potential side effects?
Potential side effects are not specified but will be monitored through health assessments during treatment with Angiotensin (1-7), comparing it against a saline placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a serious head injury with a low consciousness score.
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I am 18 years old or older.
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I am signing up within 2 days after my brain injury.
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I have had a head injury due to an external force.
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I have a brain lesion diagnosed by a CT scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to 21 days, enrollment to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to 21 days, enrollment to 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events
Performance on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Secondary outcome measures
Change in suicidal ideation and behavior as assessed by the Patient Health Questionnaire (PHQ-9)
Cognitive functions after Angiotensin (1-7) treatment as measured by the Montreal Cognitive Assessment (MoCA)
Effects of Angiotensin (1-7) on CNS damage biomarker phosphorylated tau (p-tau) after 90 days
+5 more

Side effects data

From 2011 Phase 2 trial • 34 Patients • NCT00771810
64%
Nausea
64%
Constipation
55%
Fatigue
45%
Back pain
45%
Neutropenia
45%
Thrombocytopenia
45%
Headache
36%
Anaemia
36%
Abdominal pain
36%
Dyspepsia
36%
Vomiting
27%
Leukopenia
27%
Decreased appetite
27%
Dizziness
27%
Pyrexia
18%
Insomnia
18%
Injection site pain
18%
Tinnitus
18%
Alopecia
18%
Oral pain
18%
Pain
18%
Oedema Peripheral
18%
Dysuria
9%
Abdominal discomfort
9%
Hypertensive crisis
9%
Groin Pain
9%
Gastrooesophageal reflux disease
9%
Hypertension
9%
Ascites
9%
Abdominal distension
9%
Diarrhoea
9%
Dry mouth
9%
Flatulence
9%
Infection
9%
Thirst
9%
Arthralgia
9%
Pain in extremity
9%
Neuropathy peripheral
9%
Paraesthesia
9%
Sinus headache
9%
Urinary incontinence
9%
Anxiety
9%
Restlessness
9%
Rash generalised
9%
Skin exfoliation
9%
Asthenia
9%
Gingivitis
9%
Glossodynia
9%
Oropharyngeal pain
9%
Injection site rash
9%
Hypersensitivity
9%
Weight increased
9%
Hyperglycemia
9%
Musculoskeletal pain
9%
Dyspnoea exertional
9%
Hair disorder
9%
Sinus arrhythmia
9%
Thrombocytosis
9%
Abdominal pain lower
9%
Ageusia
9%
Anorectal discomfort
9%
Regurgitation
9%
Tooth abscess
9%
Chills
9%
Influenza like illness
9%
Nodule
9%
Cholelithiasis
9%
Haematuria
9%
Urinary tract infection
9%
Vaginal disorder
9%
Sinusitis
9%
Pruritus
9%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
TXA127 100 ug/kg
Placebo
TXA127 300 ug/kg

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Ang 1-7 200 mcg/kg/dayExperimental Treatment1 Intervention
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.
Group II: Ang 1-7 100 mcg/kg/dayExperimental Treatment1 Intervention
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.
Group III: PlaceboPlacebo Group1 Intervention
Sterile saline (NaCl) will be delivered as a subcutaneous injection for 21 days.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
891 Previous Clinical Trials
332,388 Total Patients Enrolled
University of ArizonaLead Sponsor
525 Previous Clinical Trials
155,158 Total Patients Enrolled
Bellal Joseph, MDPrincipal InvestigatorUniversity of Arizona
2 Previous Clinical Trials
400 Total Patients Enrolled
~60 spots leftby Sep 2027
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