This is a randomized, placebo-controlled, subject and investigator-blinded study to evaluate efficacy, safety and tolerability of BAF312 in participants with intracerebral hemorrhage (ICH)
This was the first trial of BAF312 in ICH patients to evaluate if BAF312 had the potential to limit brain inflammation after ICH, and thereby improve neurological outcome for stroke patients when administered in addition to standard of care. ICH patients meeting study criteria were randomized at 1:1 ratio into either active or placebo group. Patients received an intravenous infusion (i.v.) treatment within 24 hours of an ICH event and were up titrated for 7 days. Following the i.v. treatment, participants received 10 mg BAF312 or placebo in tablet form (taken daily orally) for an additional 7 days. Participants were followed for an additional 76 days after treatment for neurological and safety conditions during three clinic visits. Recruitment for the trial was put on hold due to the COVID-19 pandemic. Thirty-two patients had been enrolled in the trial and completed the protocol as planned. After seven months of the trial being on hold, an Interim analysis was conducted and reviewed by the Data Monitoring Committee. Novartis terminated the trial due to lack of potential efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
Solution for intravenous (IV) infusion - 4.5mg/4.5mL
Solution for intravenous (IV) infusion - 0mg/4.5mL matching placebo
2 mg film-coated tablet
Novartis Investigative Site
Palo Alto, California, United States
Novartis Investigative Site
New Haven, Connecticut, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Absolute Perihematoma Edema (aPHE) Volume Measured by Computed Tomography (CT) Scan After Intracerebral Hemorrhage (ICH)
Following the initial diagnostic CT, repeat CT images were obtained between 24-48 h after the diagnostic scan, and on Day 7 and Day 14 to capture the trajectory of PHE increase and plateau after ICH. Only non-contrast study CT scans were obtained on Day 7 and Day 14. The non-contrast scan acquired on each patient at first follow-up (i.e. 24-48 h after the diagnostic scan) served as the baseline for our analysis. All CT scans were uploaded through a secure server, and edema and hematoma volumes were measured in a semi-automated manner by one Central Reader.
Time frame: On Day 14 following ICH
Plasma BAF312 Concentrations
Blood samples will be collected to assess plasma concentrations.
Time frame: Days 1, 8, and 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
0 mg film-coated tablet matching placebo
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Detroit, Michigan, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
...and 1 more locations