- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01144624
A Study to Assess Safety,and Tolerability of 2 Doses of AZD9773 (CytoFab™) in Japanese With Severe Sepsis/Septic Shock
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Osaka, Japan
- Research Site
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Hokkaido
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Sapporo-shi, Hokkaido, Japan
- Research Site
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Hyogo
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Kobe, Hyogo, Japan
- Research Site
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Kumamoto
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Kumamoto-Shi, Kumamoto, Japan
- Research Site
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Osaka
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Sumiyoshi-ku, Osaka, Japan
- Research Site
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Tokyo
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Hachioji, Tokyo, Japan
- Research Site
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Ohta-ku, Tokyo, Japan
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
- Haemopoietic or lymphoreticular malignancies not in remission.
- Receiving radiation therapy or chemotherapy.
- Any organ or bone marrow transplant within the past 24 weeks.
- Absolute neutrophil count <500 per μL.
- High dose steroids or other immunocompromising drugs.
Concomitant diseases:
- Deep-seated fungal infection or active tuberculosis.
- Severe chronic liver disease associated with portal hypertension, cirrhosis, chronic ascites or Child-Pugh class C.
- History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
- Neuromuscular disorders that impact breathing/spontaneous ventilation.
- Quadriplegia.
- Cardiac arrest in the past 30 days.
- New York Heart Association functional Class III or IV due to heart failure or any disorder.
- Burns over > 30% of body surface area in the past 5 days.
Medication and allergy disqualifications.
- Treatment with anti-TNF agents within the last 8 weeks.
- Previously received ovine derived products (CroFab™, DigiFab™).
- Sheep product allergy or allergy to papain, chymopapain.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 2
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Intravenous infusion of a saline solution
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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) |
A single loading dose followed by 9 maintenance doses; doses to be given every 12 hours over a period of 5 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability of AZD9773
Time Frame: 28 day study period
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Number of patients with treatment-emergent adverse events and number of patients who died over 28 days
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28 day study period
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Pharmacokinetics of AZD9773
Time Frame: From first dose to last dose (Day 5/6 or at premature treatment discontinuation)
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Maximum concentration at steady state (Cmax ss) for serum total and specific fabs
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From first dose to last dose (Day 5/6 or at premature treatment discontinuation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacodynamic Effects of AZD9773 on TNF-alpha
Time Frame: Levels taken at baseline, over the dosing period (up to Day 5/6)
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TNF-alpha levels over approximately 6 days following the first dose
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Levels taken at baseline, over the dosing period (up to Day 5/6)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wayne Dankner, MD, PAREXEL International Medical Services
- Study Director: Warren Botnick, MD, PAREXEL International Medical Services
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D0620C00005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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