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A Study to Assess Safety,and Tolerability of 2 Doses of AZD9773 (CytoFab™) in Japanese With Severe Sepsis/Septic Shock

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ClinicalTrials.gov Identifier: NCT01144624
Recruitment Status : Completed
First Posted : June 15, 2010
Results First Posted : August 22, 2013
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:

The two co-primary objectives of this study are to assess in Japanese patients with severe sepsis and/or septic shock: 1) the safety and tolerability of two different doses of intravenous AZD9773 and 2) the PK of AZD9773.

The secondary objective is to make a preliminary assessment of the pharmacodynamics of two different doses of intravenous AZD9773 in Japanese patients with severe sepsis and/or septic shock.


Condition or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Drug: AZD9773 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous Infusions of AZD9773 (CytoFab™) in Japanese Patients With Severe Sepsis and/or Septic Shock
Study Start Date : July 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1

AZD9773 250 units/kg (1 infusion) + 50 units/kg (9 infusions) (Dose Cohort 1):

AZD9773 500 units/kg (1 infusion) + 100 units/kg (9 infusions) (Dose Cohort 2)

 Drug: AZD9773
A single loading dose followed by 9 maintenance doses; doses to be given every 12 hours over a period of 5 days
Other Name: CytoFab™
Placebo Comparator: 2 Drug: Placebo
Intravenous infusion of a saline solution


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability of AZD9773 [ Time Frame: 28 day study period ]
    Number of patients with treatment-emergent adverse events and number of patients who died over 28 days

  2. Pharmacokinetics of AZD9773 [ Time Frame: From first dose to last dose (Day 5/6 or at premature treatment discontinuation) ]
    Maximum concentration at steady state (Cmax ss) for serum total and specific fabs


Secondary Outcome Measures :
  1. Pharmacodynamic Effects of AZD9773 on TNF-alpha [ Time Frame: Levels taken at baseline, over the dosing period (up to Day 5/6) ]
    TNF-alpha levels over approximately 6 days following the first dose


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese adults with a first episode of sepsis during this hospitalisation and objective evidence of infection that requires parenteral antibiotics.
  • 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:

  • Immunocompromising comorbidities or concomitant medications:

    1. Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
    2. Haemopoietic or lymphoreticular malignancies not in remission.
    3. Receiving radiation therapy or chemotherapy.
    4. Any organ or bone marrow transplant within the past 24 weeks.
    5. Absolute neutrophil count <500 per μL.
    6. High dose steroids or other immunocompromising drugs.

  • Concomitant diseases:

    1. Deep-seated fungal infection or active tuberculosis.
    2. Severe chronic liver disease associated with portal hypertension, cirrhosis, chronic ascites or Child-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 III or IV due to heart failure or any disorder.
    8. Burns over > 30% of body surface area in the past 5 days.

  • 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 papain, chymopapain.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144624


Locations
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Japan
Research Site
Sapporo-shi, Hokkaido, Japan
Research Site
Kobe, Hyogo, Japan
Research Site
Kumamoto-Shi, Kumamoto, Japan
Research Site
Sumiyoshi-ku, Osaka, Japan
Research Site
Hachioji, Tokyo, Japan
Research Site
Ohta-ku, Tokyo, Japan
Research Site
Osaka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Justin Lindemann, MD AstraZeneca
Study Director: Wayne Dankner, MD PAREXEL International Medical Services
Study Director: Warren Botnick, MD PAREXEL International Medical Services
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01144624    
Other Study ID Numbers: D0620C00005
First Posted: June 15, 2010    Key Record Dates
Results First Posted: August 22, 2013
Last Update Posted: October 6, 2014
Last Verified: September 2014
Keywords provided by AstraZeneca:
TNF neutralisation
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Shock
 Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes