A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.
Status: | Completed |
---|---|
Conditions: | Hospital, Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/6/2019 |
Start Date: | December 7, 2016 |
End Date: | January 5, 2018 |
Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936558 (Nivolumab) in Participants With Severe Sepsis or Septic Shock.
A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in
participants with severe sepsis or septic shock.
participants with severe sepsis or septic shock.
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Men and women ages ≥ 18 years old
- Documented or suspected infection
- Severe sepsis or septic shock for at least 24 hours
- Sepsis-induced immunosuppression
- In Intensive Care Unit (ICU) with no plans to discharge in next 24 hours
Exclusion Criteria:
- Previous episode of severe sepsis or septic shock with ICU admission during the
current hospitalization
- Autoimmune disease
- Organ or bone marrow transplant
- Cancer treatment in the past 6 weeks
- 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); Chronic
hepatitis B virus (HBV) infection and not on treatment
Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
16
sites
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Ann Arbor, Michigan 48109
Phone: 734-936-7469
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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