A Study to Compare the Efficacy and Safety of 2 Dosing Regimens of IV Infusions of AZD9773 (CytoFab™) With Placebo in Adult Patients With Severe Sepsis and/or Septic Shock
NCT ID: NCT01145560
Last Updated: 2014-10-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
300 participants
INTERVENTIONAL
2010-10-31
2012-05-31
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
TRIPLE
Study Groups
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1
AZD9773 250/50 units/kg
AZD9773
A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days
2
AZD9773 500/100 units/kg
AZD9773
A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days
3
Placebo
Placebo
Interventions
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AZD9773
A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 2 of 4 SIRS criteria in the 24 hours before organ dysfunction (must include either fever OR elevated white blood cells \[WBC\])
* Cardiovascular or respiratory dysfunction.
Exclusion Criteria
1. Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
2. Stage III or IV cancer.
3. Haemopoietic or lymphoreticular malignancies not in remission.
4. Receiving radiation therapy or chemotherapy.
5. Stem cell, organ or bone marrow transplant in the past 6 months.
6. Absolute neutrophil count \<500 per μL.
7. High dose steroids or other immunocompromising drugs.
* Concomitant diseases:
1. Deep seated fungal infection or active tuberculosis.
2. Cirrhosis with portal hypertension or Childs-Pugh Class C.
3. History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
4. Neuromuscular disorders that impact breathing/spontaneous ventilation.
5. Quadriplegia.
6. Cardiac arrest in the past 30 days.
7. New York Heart Association functional Class IV due to heart failure or any disorder.
8. Burns over \> 30% of body surface area.
* Medication and allergy disqualifications.
1. Treatment with anti-TNF agents within the last 8 weeks.
2. Previously received ovine derived products (CroFab™, DigiFab™).
3. Sheep product allergy or allergy to latex, papain, chymopapain.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Gordon Bernard, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Warren Botnick, MD
Role: STUDY_DIRECTOR
Parexel
Justin Lindemann, MD
Role: STUDY_DIRECTOR
AstraZeneca
Wayne Dankner, MD
Role: STUDY_DIRECTOR
Parexel
Jiri Juchelka, MD
Role: STUDY_DIRECTOR
Parexel
Locations
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Research Site
Blacktown, New South Wales, Australia
Research Site
Wollongong, New South Wales, Australia
Research Site
Herston, Queensland, Australia
Research Site
Nambour, Queensland, Australia
Research Site
Woollongabba, Queensland, Australia
Research Site
Adelaide, South Australia, Australia
Research Site
Clayton, Victoria, Australia
Research Site
Footscray, Victoria, Australia
Research Site
Fremantle, Western Australia, Australia
Research Site
Antwerp, Belgium, Belgium
Research Site
Brussels, Belgium, Belgium
Research Site
Genk, Belgium, Belgium
Research Site
Godinne, Belgium, Belgium
Research Site
Liège, Belgium, Belgium
Research Site
Ottignies, Belgium, Belgium
Research Site
Edmonton, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Victoria, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Halifax, Nova Scotia, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Windsor, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Hradec Králové, , Czechia
Research Site
Prague, , Czechia
Research Site
Ústí nad Labem, , Czechia
Research Site
Kuopio, , Finland
Research Site
Tampere, , Finland
Research Site
Angers, , France
Research Site
Dijon, , France
Research Site
La Roche-sur-Yon, , France
Research Site
Limoges, , France
Research Site
Montauban, , France
Research Site
Nantes, , France
Research Site
Nîmes, , France
Research Site
Orléans, , France
Research Site
Paris, , France
Research Site
Poitiers, , France
Research Site
Saint-Michel, , France
Research Site
Toulon, , France
Research Site
Toulouse, , France
Research Site
Tours, , France
Research Site
Vandœuvre-lès-Nancy, , France
Research Site
Palma de Mallorca, Balearic Islands, Spain
Research Site
Sabadell, Barcelona, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
Terrassa, Catalonia, Spain
Research Site
Santiago de Compostela, Coruna, Spain
Research Site
Getafe, Madrid, Spain
Research Site
Madrid, Madrid, Spain
Research Site
Oviedo, Principality of Asturias, Spain
Research Site
Valencia, Valencia, Spain
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.
Related Links
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Other Identifiers
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D0620C00003
Identifier Type: -
Identifier Source: org_study_id
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