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

NCT07701512 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Feb in ICH
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the effect of Febuxostat on clinical outcomes and biomarkers of oxidative stress and inflammation in patients with conservatively managed intracranial hemorrhage.

Conditions

Intracranial Hemorrhage

Keywords

Intracranial hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline,1week,1monthand 3 months

Secondary Outcomes (5)

• Radiological assessment via non-contrast computed tomography (NCCT)

  Baseline and 3 months

• Change from baseline in C-reactive protein (CRP) level at 3 months

  Baseline and 3 months

• Change from baseline in Erythrocyte sedimentation rate (ESR) at 3 months.

  Baseline and 3 months

• Change from baseline in Serum Interleukin-1 beta (IL-1β) at 3 months.

  Baseline and 3 months

• Change from baseline in Serum S100B protein at 3 months.

  Baseline and 3 months

Study Arms (2)

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

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.

Drug: Standard medical treatment

Interventions

Febuxostat 40 mg DRUG

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

Febuxostat + standard medical treatment

Standard medical treatment DRUG

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

Febuxostat + standard medical treatment; Standard medical treatment only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Neurosurgery department Mansoura university hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 34605668 BACKGROUND

• Bai 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.

  PMID: 38645501 BACKGROUND

MeSH Terms

Conditions

Intracranial Hemorrhages

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mertihan E Elhadidi

CONTACT

+201124955511; Merihanelhadidy9@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind study where the participants (patients) are blinded to the treatment assigned. Medications and standard care are administered while ensuring that the participant remains unaware of whether they are receiving Febuxostat or standard therapy alone
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacist

Model Details: 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

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: November 20, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)