Intracranial HemorrhagePhase 2NCT07701512
Clinical Study to Evaluate the Efficacy of Febuxostat in the Treatment of Conservatively Managed Intracranial Hemorrhage Patients
A Phase 2 study testing Febuxostat 40 mg and Standard medical treatment in people with Intracranial Hemorrhage, run by Tanta University at 1 site in Egypt.
Trial summary
To assess the effect of Febuxostat on clinical outcomes and biomarkers of oxidative stress and inflammation in patients with conservatively managed intracranial hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hemorrhage
- What is being tested?
- Febuxostat 40 mg and Standard medical treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2025to 30 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age ≥ 18 years old.
- Diagnosed with intracranial hemorrhage confirmed by CT scan.
- Managed conservatively regarding clinical guidelines.
- Able to provide informed consent or have a legal representative provide consent.
Who cannot join
- • Patients with a history of previous brain surgery or significant neurological disorders.
- Severe comorbidities (e.g., uncontrolled diabetes, severe cardiac disease).
- Allergy or contraindication to febuxostat.
- Pregnant or breastfeeding women.
- Patients requiring surgical intervention for hematoma evacuation.
- Renal impairment with SCr > 4
- Liver impairment with INR > 5
- Significant deterioration ( GCS < 8 )
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Neurosurgery department Mansoura university hospitals
Al Mansurah, Dakahlia Governorate, 35511
Merihan Elhadidi Elhadidi, Clinical pharmacist, +201124955512, Merihanelhadidy9@gmail.com
About this study
To assess the effect of Febuxostat on clinical outcomes and biomarkers of oxidative stress and inflammation in patients with conservatively managed intracranial hemorrhage.
Read the detailed description
Intracranial hemorrhage (ICH) is a severe neurological condition characterized by bleeding within the intracranial vault, including the brain parenchyma and surrounding meningeal spaces .
It is associated with high mortality and significant morbidity, often leading to severe neurological dysfunctions . ICH can be classified into various subtypes based on the anatomical location of bleeding, including intraparenchymal hemorrhage (IPH), subarachnoid hemorrhage (SAH), subdural hematoma (SDH), epidural hematoma (EDH), and intraventricular hemorrhage (IVH) .
The pathophysiology of ICH involves both primary and secondary brain injuries. Primary brain injury results from direct mechanical damage caused by the hematoma, while secondary brain injury (SBI) is driven by oxidative stress, neuroinflammation, and disruption of the blood-brain barrier (BBB). Oxidative stress, in particular, plays a significant role in ICH progression, as the overproduction of reactive oxygen species (ROS) leads to cellular apoptosis, lipid peroxidation, and neuronal damage. Inflammatory responses further exacerbate brain injury, contributing to cognitive dysfunction and neurodegeneration .
Uric acid (UA), the end product of purine metabolism, is catalyzed by xanthine oxidase (XO) and has been implicated in cerebrovascular diseases due to its pro-oxidant properties. Hyperuricemia is associated with an increased risk of coronary heart disease, ischemic stroke, diabetes, hypertension, chronic kidney disease, and gout. Moreover, elevated UA levels may worsen ICH prognosis, leading to higher mortality and more severe symptoms.
Xanthine oxidase plays a crucial role in ROS production during the conversion of hypoxanthine to xanthine and UA, generating hydrogen peroxide (H₂O₂) and superoxide anion (O₂-), both of which contribute to oxidative stress and vascular damage. These oxidative molecules increase microvascular permeability and can further propagate secondary brain injury in ICH .
A powerful non-purine selective xanthine oxidase inhibitor (XOI), Febuxostat was approved by the FDA in 2009 for the treatment hyperuricemia in gout patients. According to recent research, Feb has neuroprotective effects on cerebral ischemia-reperfusion in rats and is beneficial against cardiac ischemia-reperfusion injury. In animal studies, Feb helped neurocognitive performance in mice following a brain hemorrhage. Feb was more likely to be involved in neuroprotection following cerebral hemorrhage by influencing inflammation-related pathways, based on analysis of genes after hemorrhage. Feb could attenuate the activation of the NLRP3 inflammasome, a crucial inflammatory molecule in neuroinflammation, and lower the level of inflammatory factors following cerebral hemorrhage. Feb also lowered neuronal degeneration and neuronal death in brain tissues. The protective benefits of Feb were discovered following secondary injury in cerebral hemorrhage using bioinformatics and pharmacological approaches.
While preclinical research in animal models is promising, transferring these findings into clinical applications is essential to assess the neuroprotective effect of Feb in patients with intracranial hemorrhage, human model.
- Conditions
- Intracranial Hemorrhage
- Being tested
- Febuxostat 40 mg, Standard medical treatment
- Keywords
- Intracranial hemorrhage
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Febuxostat 40 mgDrug
Participants in this arm will receive Febuxostat at a dose of 40 mg orally once daily for a duration of three months, administered in addition to the standard traditional therapy for conservatively managed intracranial hemorrhage
Standard medical treatmentDrug
Participants in this arm will receive only the standard traditional medical guidelines and therapy for conservatively managed intracranial hemorrhage for a duration of three months
| Study group | Role | What they receive |
|---|---|---|
| Febuxostat + standard medical treatment | Experimental | Patients will receive Febuxostat 40 mg once daily in addition to the standard medical treatment of conservatively managed intracranial hemorrhage for three months Receives: Drug: Febuxostat 40 mg; Drug: Standard medical treatment |
| Standard medical treatment only | Active comparator | Patients will receive only the standard medical treatment of conservatively managed intracranial hemorrhage for three months. Receives: Drug: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in glasgow coma scale
The GCS is used to assess the patient's level of consciousness based on eye, verbal, and motor responses, with a total score ranging from 3 (severe impairment) to 15 (normal). Higher scores indicate better clinical outcomes
Measured: Baseline,1week,1monthand 3 months
Secondary outcomes (5)
Radiological assessment via non-contrast computed tomography (NCCT)
NCCT imaging will be used to evaluate hematoma stability, resolution, expansion, or complications (such as perihematomal edema, mass effect, or midline shift) in intracranial hemorrhage patients.
Measured: Baseline and 3 months
Change from baseline in C-reactive protein (CRP) level at 3 months
Blood samples will be analyzed to measure the change in levels of specific inflammatory biomarkers to evaluate the effect of Febuxostat on neuroinflammation and oxidative stress. The biomarkers include:
C-reactive protein (CRP) level ( mg/l)
Measured: Baseline and 3 months
Change from baseline in Erythrocyte sedimentation rate (ESR) at 3 months.
Blood samples will be analyzed to measure the change in levels of specific inflammatory biomarkers to evaluate the effect of Febuxostat on neuroinflammation and oxidative stress. The biomarkers include:
Erythrocyte sedimentation rate (ESR) (mm/hr)
Measured: Baseline and 3 months
Change from baseline in Serum Interleukin-1 beta (IL-1β) at 3 months.
Blood samples will be analyzed to measure the change in levels of specific inflammatory biomarkers to evaluate the effect of Febuxostat on neuroinflammation and oxidative stress. The biomarkers include:
Interleukin-1 beta (IL-1β) (pg/mL).
Measured: Baseline and 3 months
Change from baseline in Serum S100B protein at 3 months.
Blood samples will be analyzed to measure the change in levels of specific inflammatory biomarkers to evaluate the effect of Febuxostat on neuroinflammation and oxidative stress. The biomarkers include:
Serum S100B protein (pg/mL).
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start20 Nov 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial HemorrhageStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Model description
- A randomized, controlled, parallel-group, single-blind clinical trial. Eligible participants are assigned in a 1:1 ratio to either the active interventional group (receiving Febuxostat 40 mg once daily plus standard traditional therapy) or the positive control group (receiving standard traditional therapy only) for a total duration of 3 months
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merihan Elhadidi Elhadidi, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701512
- Sponsor's protocol ID
- Feb in ICH
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bodien YG, Barra A, Temkin NR, Barber J, Foreman B, Vassar M, Robertson C, Taylor SR, Markowitz AJ, Manley GT, Giacino JT, Edlow BL; TRACK-TBI Investigators. Diagnosing Level of Consciousness: The Limits of the Glasgow Coma Scale Total Score. J Neurotrauma. 2021 Dec;38(23):3295-3305. doi: 10.1089/neu.2021.0199.
PubMed 34605668Bai Y, Shi H, Zhang Y, Zhang C, Wu B, Wu X, Fang Z, Wang Q, Sima X, Zhang T. Febuxostat attenuates secondary brain injury caused by cerebral hemorrhage through inhibiting inflammatory pathways. Iran J Basic Med Sci. 2024;27(6):740-746. doi: 10.22038/IJBMS.2024.74655.16212.
PubMed 38645501
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efficacy of Febuxostat in the Treatment of Conservatively Managed Intracranial Hemorrhage Patients
- ClinicalTrials.gov ID
- NCT07701512
- Acronym / sponsor ID
- Feb in ICH
- Conditions
- Intracranial Hemorrhage
- Keywords
- Intracranial hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- 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.
To assess the effect of Febuxostat on clinical outcomes and biomarkers of oxidative stress and inflammation in patients with conservatively managed intracranial hemorrhage.
Detailed description
Intracranial hemorrhage (ICH) is a severe neurological condition characterized by bleeding within the intracranial vault, including the brain parenchyma and surrounding meningeal spaces .
It is associated with high mortality and significant morbidity, often leading to severe neurological dysfunctions . ICH can be classified into various subtypes based on the anatomical location of bleeding, including intraparenchymal hemorrhage (IPH), subarachnoid hemorrhage (SAH), subdural hematoma (SDH), epidural hematoma (EDH), and intraventricular hemorrhage (IVH) .
The pathophysiology of ICH involves both primary and secondary brain injuries. Primary brain injury results from direct mechanical damage caused by the hematoma, while secondary brain injury (SBI) is driven by oxidative stress, neuroinflammation, and disruption of the blood-brain barrier (BBB). Oxidative stress, in particular, plays a significant role in ICH progression, as the overproduction of reactive oxygen species (ROS) leads to cellular apoptosis, lipid peroxidation, and neuronal damage. Inflammatory responses further exacerbate brain injury, contributing to cognitive dysfunction and neurodegeneration .
Uric acid (UA), the end product of purine metabolism, is catalyzed by xanthine oxidase (XO) and has been implicated in cerebrovascular diseases due to its pro-oxidant properties. Hyperuricemia is associated with an increased risk of coronary heart disease, ischemic stroke, diabetes, hypertension, chronic kidney disease, and gout. Moreover, elevated UA levels may worsen ICH prognosis, leading to higher mortality and more severe symptoms.
Xanthine oxidase plays a crucial role in ROS production during the conversion of hypoxanthine to xanthine and UA, generating hydrogen peroxide (H₂O₂) and superoxide anion (O₂-), both of which contribute to oxidative stress and vascular damage. These oxidative molecules increase microvascular permeability and can further propagate secondary brain injury in ICH .
A powerful non-purine selective xanthine oxidase inhibitor (XOI), Febuxostat was approved by the FDA in 2009 for the treatment hyperuricemia in gout patients. According to recent research, Feb has neuroprotective effects on cerebral ischemia-reperfusion in rats and is beneficial against cardiac ischemia-reperfusion injury. In animal studies, Feb helped neurocognitive performance in mice following a brain hemorrhage. Feb was more likely to be involved in neuroprotection following cerebral hemorrhage by influencing inflammation-related pathways, based on analysis of genes after hemorrhage. Feb could attenuate the activation of the NLRP3 inflammasome, a crucial inflammatory molecule in neuroinflammation, and lower the level of inflammatory factors following cerebral hemorrhage. Feb also lowered neuronal degeneration and neuronal death in brain tissues. The protective benefits of Feb were discovered following secondary injury in cerebral hemorrhage using bioinformatics and pharmacological approaches.
While preclinical research in animal models is promising, transferring these findings into clinical applications is essential to assess the neuroprotective effect of Feb in patients with intracranial hemorrhage, human model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized, controlled, parallel-group, single-blind clinical trial. Eligible participants are assigned in a 1:1 ratio to either the active interventional group (receiving Febuxostat 40 mg once daily plus standard traditional therapy) or the positive control group (receiving standard traditional therapy only) for a total duration of 3 months
| Arm | Type | Receives |
|---|---|---|
| Febuxostat + standard medical treatment | Experimental | Drug: Febuxostat 40 mg, Drug: Standard medical treatmentPatients will receive Febuxostat 40 mg once daily in addition to the standard medical treatment of conservatively managed intracranial hemorrhage for three months |
| Standard medical treatment only | Active comparator | Drug: Standard medical treatmentPatients will receive only the standard medical treatment of conservatively managed intracranial hemorrhage for three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Age ≥ 18 years old.
Key exclusion criteria (8 listed)
- • Patients with a history of previous brain surgery or significant neurological disorders.
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 |
|---|---|---|
| Febuxostat 40 mgParticipants in this arm will receive Febuxostat at a dose of 40 mg orally once daily for a duration of three months, administered in addition to the standard traditional therapy for conservatively managed intracranial hemorrhage | Drug | Febuxostat + standard medical treatment |
| Standard medical treatmentParticipants in this arm will receive only the standard traditional medical guidelines and therapy for conservatively managed intracranial hemorrhage for a duration of three months | Drug | Febuxostat + standard medical treatment, Standard medical treatment only |
Primary outcome
Change from baseline in glasgow coma scale
Time frame: Baseline,1week,1monthand 3 months
The GCS is used to assess the patient's level of consciousness based on eye, verbal, and motor responses, with a total score ranging from 3 (severe impairment) to 15 (normal). Higher scores indicate better clinical outcomes
5 secondary outcomes
Radiological assessment via non-contrast computed tomography (NCCT)
Time frame: Baseline and 3 months
Change from baseline in C-reactive protein (CRP) level at 3 months
Time frame: Baseline and 3 months
Change from baseline in Erythrocyte sedimentation rate (ESR) at 3 months.
Time frame: Baseline and 3 months
Change from baseline in Serum Interleukin-1 beta (IL-1β) at 3 months.
Time frame: Baseline and 3 months
Change from baseline in Serum S100B protein at 3 months.
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 34605668Bodien YG, Barra A, Temkin NR, Barber J, Foreman B, Vassar M, Robertson C, Taylor SR, Markowitz AJ, Manley GT, Giacino JT, Edlow BL; TRACK-TBI Investigators. Diagnosing Level of Consciousness: The Limits of the Glasgow Coma Scale Total Score. J Neurotrauma. 2021 Dec;38(23):3295-3305. doi: 10.1089/neu.2021.0199.
- Background: PubMed 38645501Bai Y, Shi H, Zhang Y, Zhang C, Wu B, Wu X, Fang Z, Wang Q, Sima X, Zhang T. Febuxostat attenuates secondary brain injury caused by cerebral hemorrhage through inhibiting inflammatory pathways. Iran J Basic Med Sci. 2024;27(6):740-746. doi: 10.22038/IJBMS.2024.74655.16212.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Febuxostat 40 mg and Standard medical treatment in people with Intracranial Hemorrhage, run by Tanta University at 1 site in Egypt.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mertihan E Elhadidi (+201124955511, Merihanelhadidy9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in glasgow coma scale (time frame: Baseline,1week,1monthand 3 months). 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 NCT07701512, which also lists 2 linked publications.
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 15 Jul 2026.