Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2008-01-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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AZD9773 cohort 1 (50 units/kg)
AZD9773: single infusion of 50 units/kg
AZD9773 (CytoFab)
intravenous infusions
AZD9773 cohort 2 (250 units/kg)
AZD9773: single infusion of 250 units/kg
AZD9773 (CytoFab)
intravenous infusions
AZD9773 cohort 3 (250/50 units/kg)
AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
AZD9773 (CytoFab)
intravenous infusions
AZD9773 cohort 4 (500/100 units/kg)
AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
AZD9773 (CytoFab)
intravenous infusions
AZD9773 cohort 5 (750/250 units/kg)
AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
AZD9773 (CytoFab)
intravenous infusions
Placebo
Placebo
Placebo
Placebo
Interventions
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AZD9773 (CytoFab)
intravenous infusions
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Patients must meet multiple Systemic Inflammatory Response Syndrome (SIRS) criteria
* Patients must meet criteria for cardiovascular and/or respiratory dysfunction
* Sepsis (infection plus SIRS criteria) must be present prior to organ dysfunction
Exclusion Criteria
* Patient cannot attain a MAP \>60 mmHg when measured via an arterial line and/or a Systolic Blood Pressure (SBP) \>80 mmHg in the presence of vasopressors and iv fluids for a period of ≥2 hours
* Receiving immunosuppressants, or high dose steroids within 2 months of provision of informed consent
* Any history of hypersensitivity reaction to sheep products, latex, papain or papaya, or chymopapain or previously administered antivenom manufactured using ovine serum, digoxin immune fab (DigiFab™ , DIGIBIND® ), crotalidae polyvalent immune fab (ovine) (CroFab™ ), or other sheep derived product.
* Treatment with anti Tumor-Necrosis-Factor (anti-TNF) antibodies within 8 weeks before provision of written informed consent.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Simonson, MD
Role: STUDY_DIRECTOR
AstraZeneca
Wayne Dankner, MD
Role: STUDY_DIRECTOR
Parexel
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Newark, Delaware, United States
Research Site
Bay Pines, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Oak Park, Illinois, United States
Research Site
Peoria, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Iowa City, Iowa, United States
Research Site
Hazard, Kentucky, United States
Research Site
Lexington, Kentucky, United States
Research Site
Baltimore, Maryland, United States
Research Site
Kansas City, Missouri, United States
Research Site
Camden, New Jersey, United States
Research Site
Newark, New Jersey, United States
Research Site
Brooklyn, New York, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Nashville, Tennessee, United States
Research Site
Galveston, Texas, United States
Research Site
Houston, Texas, United States
Countries
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References
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Yates JW, Das S, Mainwaring G, Kemp J. Population pharmacokinetic/pharmacodynamic modelling of the anti-TNF-alpha polyclonal fragment antibody AZD9773 in patients with severe sepsis. J Pharmacokinet Pharmacodyn. 2012 Dec;39(6):591-9. doi: 10.1007/s10928-012-9270-4. Epub 2012 Sep 23.
Other Identifiers
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D0620C00004
Identifier Type: -
Identifier Source: org_study_id