Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms

Recruiting now · Phase 1/Phase 2

Conditions studied: Aneurysm, Stroke, Vasculitis, Tumor Necrosis Factor-alpha

In brief

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

Key facts

Study ID: NCT02638701
Run by: University of California, San Francisco
People needed: 8
Starts: 2024-10-01
Expected to finish: 2028-12-01
Last updated by the study team: 2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Use of an anti-TNF or other biologic medication (Including but not limited to abatacept, rituximab, or tocilizumab) within the previous 12 months.
The following laboratory parameters at the Screening visit: Neutropenia (absolute neutrophil count < 1,500/microliter; Thrombocytopenia (platelets < 100,000/ • Anemia (hemoglobin < 8 g/dL); Greater than or equal to 3 times the upper limit of normal (ULN) for either of the following liver function tests (LFTs): aspartate transaminase (AST) or alanine transaminase (ALT); Renal insufficiency (serum creatinine> 2.0 mg/dL)
Purified protein derivative (PPD) test of > 5 mm induration regardless of prior BacilleCalmette Guerin vaccine administration or positive QuantiFERON®-TB Gold In-Tube Test (QFT-G_IT) without documentation of completed treatment or evidence of ongoing treatment of latent tuberculosis (TB) for 30 days. Subjects with active TB infection are excluded.
History of positive PPD, positive QuantiFERON®-TB Gold In-Tube Test (QFT-G_IT), or chest x-ray findings indicative of prior TB infection, without documentation of either treatment for TB infection or chemoprophylaxis for TB exposure
Presence of open leg ulcers
Chronic or persistent infection including but not limited to human immunodeficiency virus [HIV], untreated hepatitis B, listeriosis, TB, or other opportunistic infection). Patients with hepatitis C but without evidence of cirrhosis or significant hepatic dysfunction will be considered for inclusion on a case-by-case basis as will patients with chronic hepatitis B on anti-viral therapy.
Active infection or severe infections requiring hospitalization or treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to randomization, or oral antibiotics, oral antivirals, or oral 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 other than treated localized carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell skin carcinoma
Any medical condition, which, in the opinion of the investigator, would put the subject at risk by participation in the protocol
Women of childbearing potential who are sexually active and who do not agree to practice one of the following methods of contraception during the duration of the study: condoms, sponge, foams, jellies, diaphragm or intrauterine device; oral or parenteral contraceptives for 2 months prior to study product administration; a vasectomized partner; abstinence.
Pregnant (all women of childbearing potential must have a negative serum pregnancy test) or breastfeeding
Any investigational agent within the earlier of 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
Any psychiatric disorder that prevents the subject from providing informed consent
Inability or unwillingness to follow the protocol.
Unable to undergo MR imaging.

Where it is running

UCSF Medical Center — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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