Septic Shock Clinical Trial
Official title:
A Phase 1b/2a, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Subjects With Severe Sepsis
Verified date | September 2017 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether BMS-936559 is safe and has the desired pharmacologic activity in patients who have severe sepsis.
Status | Terminated |
Enrollment | 35 |
Est. completion date | March 15, 2017 |
Est. primary completion date | March 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com Inclusion Criteria: - Severe sepsis or septic shock for at least 24 hours - Documented or suspected infection - Sepsis-induced immunosuppression - Men and women = 18 years old Exclusion Criteria: - Autoimmune disease - 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan, Division of Acute Care Surgery | Ann Arbor | Michigan |
United States | Emory University | Atlanta | Georgia |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | The Ohio State University | Columbus | Ohio |
United States | Local Institution | Denver | Colorado |
United States | University Of Florida | Gainesville | Florida |
United States | Osf Saint Francis Medical Center | Peoria | Illinois |
United States | UPMC | Pittsburgh | Pennsylvania |
United States | Uc Davis Medical Center | Sacramento | California |
United States | Washington University School Of Medicine | Saint Louis | Missouri |
United States | Local Institution | Seattle | Washington |
United States | Baystate Medical Center | Springfield | Massachusetts |
United States | St. Vincent'S Medical Center | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1: Safety of BMS-936559 in subjects with severe sepsis - measured by the incidence rates of death, AEs, SAEs, AEs leading to discontinuation, AEs of special interest and laboratory abnormalities | Safety will be measured by the incidence rates of death, Adverse event (AEs), Serious adverse event (SAEs), AEs leading to discontinuation, AEs of special interest (identified from PD-L1 oncology trial), and laboratory abnormalities | Approximately 3 months | |
Primary | Part 1: Tolerability of BMS-936559 in subjects with severe sepsis | Tolerability will be measured by the incidence rates of death, AEs, SAEs, AEs leading to discontinuation, AEs of special interest (identified from PD-L1 oncology trial), and laboratory abnormalities | Approximately 3 months | |
Primary | Part 2: All-cause mortality within 90 days of study drug administration | Approximately 3 months | ||
Secondary | Maximum observed serum concentration (Cmax) of BMS-936559 | Approximately 3 months | ||
Secondary | Time of maximum observed serum concentration (Tmax) of BMS-936559 | Approximately 3 months | ||
Secondary | Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-936559 | Approximately 3 months | ||
Secondary | Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-936559 | Approximately 3 months | ||
Secondary | Total Body Clearance (CLT) of BMS-936559 | Approximately 3 months | ||
Secondary | Volume of distribution at steady state (Vss) of BMS-936559 | Approximately 3 months | ||
Secondary | Terminal serum half-life (T-HALF) of BMS-936559 | Approximately 3 months | ||
Secondary | Receptor occupancy based on PD-L1 receptor occupancy levels | Approximately 3 months | ||
Secondary | Immune system function based on baseline and post-dosing assessments of mHLA-DR expression on monocytes at planned sampling timepoints | Approximately 3 months | ||
Secondary | Immune system function based on absolute lymphocyte counts at planned sampling timepoints | Approximately 3 months | ||
Secondary | Immune system function based on lipopolysaccharide (LPS)-induced whole blood TNFalpha production levels at planned sampling timepoints | Approximately 3 months | ||
Secondary | Organ dysfunction measured by organ support-free days (OSFDs) | OSFD is defined as the last period of organ support-free duration during the index hospitalization stay prior to discharge. | Approximately 3 months | |
Secondary | Organ dysfunction measured by proportion of OSFDs during index hospitalization | OSFD is defined as the last period of organ support-free duration during the index hospitalization stay prior to discharge. | Approximately 3 months | |
Secondary | Duration of mechanical ventilation, vasopressor use, and/or dialysis use separately during the index hospitalization | Approximately 3 months | ||
Secondary | Incidence of secondary infections (as adjudicated by a clinical committee) up to 90 days post administration of BMS-936559 | Approximately 3 months | ||
Secondary | All-cause mortality at 28 days, 90 days, and 1 year after study drug administration | All-cause mortality at 28 days, 90 days, and 1 year post administration of BMS-936559. Time to death will also be used to assess the treatment effect. |
Approximately 3 months | |
Secondary | Immunogenicity measured by number of subjects having detectable anti-drug antibodies (ADA) at baseline and following administration of BMS-936559. | Approximately 3 months | ||
Secondary | Immunogenicity measured by percentage of subjects having detectable anti-drug antibodies (ADA) at baseline and following administration of BMS-936559. | Approximately 3 months |
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