Clinical Study to Evaluate the Efficacy of Febuxostat in the Treatment of Conservatively Managed Intracranial Hemorrhage Patients

July 14, 2026 updated by: Merihan Elhadidi Elhadidi, Tanta University
To assess the effect of Febuxostat on clinical outcomes and biomarkers of oxidative stress and inflammation in patients with conservatively managed intracranial hemorrhage.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt, 35511
        • Recruiting
        • Neurosurgery department Mansoura university hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • • 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 )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Febuxostat + standard medical treatment
Patients will receive Febuxostat 40 mg once daily in addition to the standard medical treatment of conservatively managed intracranial hemorrhage for three months
Drug: Febuxostat 40 mg
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
Drug: Standard medical treatment
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
Active Comparator: Standard medical treatment only
Patients will receive only the standard medical treatment of conservatively managed intracranial hemorrhage for three months.
Drug: Standard medical treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline,1week,1monthand 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological assessment via non-contrast computed tomography (NCCT)
Time Frame: Baseline and 3 months
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.
Baseline and 3 months
Change from baseline in C-reactive protein (CRP) level at 3 months
Time Frame: Baseline and 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)
Baseline and 3 months
Change from baseline in Erythrocyte sedimentation rate (ESR) at 3 months.
Time Frame: Baseline and 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)
Baseline and 3 months
Change from baseline in Serum Interleukin-1 beta (IL-1β) at 3 months.
Time Frame: Baseline and 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).
Baseline and 3 months
Change from baseline in Serum S100B protein at 3 months.
Time Frame: Baseline and 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).
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2025

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Feb in ICH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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