Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Dec 19, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people who have a specific type of brain aneurysm called a dolichoectactic vertebrobasilar (DVB) aneurysm. These aneurysms are abnormal bulges in important arteries at the base of the brain, which can lead to serious problems like bleeding in the brain, stroke, or pressure on vital brain areas. Currently, many patients with this condition cannot have surgery or other invasive treatments because these methods often don’t work well. This study is testing whether a medication called infliximab, which targets inflammation, might help manage these aneurysms in a safer, non-surgical way.

People who might be eligible to join this study are adults over 18 years old who have a DVB aneurysm that cannot be treated with surgery or other common procedures. The trial is open to both men and women, but there are some important health requirements. For example, participants should not have recent infections, active tuberculosis, certain blood or liver problems, or recent use of similar medications. Women who can become pregnant must use reliable birth control during the study, and pregnant or breastfeeding women cannot participate. If you join the trial, you will receive the study treatment and be monitored closely to see how well it works and how safe it is. This research is still in an early phase, meaning it’s primarily focused on safety and understanding how the treatment affects the body.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Vertebral and/or basilar artery dolichoectactic aneurysm not amenable to microsurgical or endovascular treatment.
• • 2. Age greater than 18 years at time of first study drug administration.
• Exclusion Criteria:
• • 1. Use of an anti-TNF or other biologic medication (Including but not limited to abatacept, rituximab, or tocilizumab) within the previous 12 months.
• • 2. 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)
• • 3. 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.
• • 4. 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
• • 5. Presence of open leg ulcers
• • 6. 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.
• • 7. 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
• • 8. Receipt of a live vaccine within 4 weeks prior to randomization
• • 9. 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
• • 10. Any medical condition, which, in the opinion of the investigator, would put the subject at risk by participation in the protocol
• • 11. 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.
• • 12. Pregnant (all women of childbearing potential must have a negative serum pregnancy test) or breastfeeding
• • 13. Any investigational agent within the earlier of 4 weeks or 5 half-lives prior to randomization
• • 14. History of drug or alcohol abuse within 6 months prior to randomization
• • 15. Known allergy or hypersensitivity to any study products
• • 16. Any psychiatric disorder that prevents the subject from providing informed consent
• • 17. Inability or unwillingness to follow the protocol.
• • 18. Unable to undergo MR imaging.