Safety, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Severe Sepsis
NCT ID: NCT02576457
Last Updated: 2017-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
35 participants
INTERVENTIONAL
2015-12-02
2017-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BMS-936559
BMS-936559 Intravenous infusion on specified days
BMS-936559
Placebo
Placebo on specified days
Placebo
Interventions
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BMS-936559
Placebo
Eligibility Criteria
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Inclusion Criteria
* Documented or suspected infection
* Sepsis-induced immunosuppression
* Men and women ≥ 18 years old
Exclusion Criteria
* Organ transplant or bone marrow transplant
* Cancer treated in the past 6 months
* Hepatitis B virus (HBV) Infection
* Human Immunodeficiency Virus (HIV) infection and not on therapy prior to this episode of sepsis
* Hepatitis C virus (HCV) infection and still has virus (not cured)
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Uc Davis Medical Center
Sacramento, California, United States
Local Institution
Denver, Colorado, United States
University Of Florida
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
Osf Saint Francis Medical Center
Peoria, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Michigan, Division of Acute Care Surgery
Ann Arbor, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
The Ohio State University
Columbus, Ohio, United States
St. Vincent'S Medical Center
Toledo, Ohio, United States
UPMC
Pittsburgh, Pennsylvania, United States
Local Institution
Seattle, Washington, United States
Countries
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References
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Hotchkiss RS, Colston E, Yende S, Angus DC, Moldawer LL, Crouser ED, Martin GS, Coopersmith CM, Brakenridge S, Mayr FB, Park PK, Ye J, Catlett IM, Girgis IG, Grasela DM. Immune Checkpoint Inhibition in Sepsis: A Phase 1b Randomized, Placebo-Controlled, Single Ascending Dose Study of Antiprogrammed Cell Death-Ligand 1 Antibody (BMS-936559). Crit Care Med. 2019 May;47(5):632-642. doi: 10.1097/CCM.0000000000003685.
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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AI471-049
Identifier Type: -
Identifier Source: org_study_id