Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT02638701

Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms

Led by University of California, San Francisco · Updated on 2025-07-08

8

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Patients harboring dolichoectactic vertebrobasilar (DVB) aneurysms are at risk of suffering SAH, ischemic stroke, and/or brainstem compression and many patients are not offered invasive treatment due to the futility of existing surgical methods. Consequently, there is demand for development of medical therapy for DVB aneurysms

CONDITIONS

Official Title

Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Vertebral and/or basilar artery dolichoectactic aneurysm not amenable to microsurgical or endovascular treatment.
  • Age greater than 18 years at time of first study drug administration.
Not Eligible

You will not qualify if you...

  • Use of an anti-TNF or other biologic medication within the previous 12 months.
  • Neutropenia (absolute neutrophil count < 1,500/microliter).
  • Thrombocytopenia (platelets < 100,000).
  • Anemia (hemoglobin < 8 g/dL).
  • Liver function tests (AST or ALT) greater than or equal to 3 times the upper limit of normal.
  • Renal insufficiency (serum creatinine > 2.0 mg/dL).
  • Positive purified protein derivative (PPD) test > 5 mm induration without completed treatment for latent tuberculosis.
  • Positive QuantiFERON-TB Gold test without completed treatment or ongoing treatment for latent tuberculosis.
  • Active tuberculosis infection.
  • History of positive PPD, positive QuantiFERON-TB Gold test, or chest x-ray findings indicating prior tuberculosis without treatment documentation.
  • Presence of open leg ulcers.
  • Chronic or persistent infections including HIV, untreated hepatitis B, listeriosis, tuberculosis, or other opportunistic infections.
  • Active or severe infections requiring hospitalization or intravenous treatment within 30 days prior to randomization.
  • Use of oral antibiotics, antivirals, or antifungals within 14 days prior to randomization.
  • Receipt of a live vaccine within 4 weeks prior to randomization.
  • History of malignancy within the past 5 years except treated localized carcinoma in situ of the cervix or treated non-metastatic skin carcinoma.
  • Any medical condition that would pose risk during the study.
  • Women of childbearing potential who are sexually active and do not agree to use effective contraception during the study.
  • Pregnant or breastfeeding women.
  • Use of any investigational agent within 4 weeks or 5 half-lives prior to randomization.
  • History of drug or alcohol abuse within 6 months prior to randomization.
  • Known allergy or hypersensitivity to any study products.
  • Psychiatric disorder preventing informed consent.
  • Inability or unwillingness to follow the study protocol.
  • Unable to undergo MRI scanning.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UCSF Medical Center

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

D

Daniel L Cooke, MD

CONTACT

J

Jonathan Graf, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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