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NCT02638701RecruitingPhase 1/2

Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms

Source: ClinicalTrials.gov · Last updated 11 Jun 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
8 (estimated)
First submitted
15 Dec 2015
Start date
1 Oct 2024
Primary completion date
30 Jun 2028
Lead sponsor
University of California, San Francisco
Diseases
Stroke
NCT number
NCT02638701

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 8
  • From 1 Oct 2024 to the primary completion date, 30 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of an anti-TNF or other biologic medication (Including but not limited to abatacept, rituximab, or tocilizumab) within the previous 12 months.
  • 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
  • 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
  • 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.
  • 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

Other illness

  • 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.
  • 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
  • Known allergy or hypersensitivity to any study products
  • Any psychiatric disorder that prevents the subject from providing informed consent

Lab values

  • 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)
  • Pregnant (all women of childbearing potential must have a negative serum pregnancy test) or breastfeeding

Other

  • Presence of open leg ulcers
  • Inability or unwillingness to follow the protocol.
  • Unable to undergo MR imaging.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UCSF Medical Center
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.