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 |
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Recruitment Status :
Completed
First Posted : June 15, 2010
Results First Posted : August 22, 2013
Last Update Posted : October 6, 2014
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions |
Severe Sepsis Septic Shock |
| Interventions |
Drug: AZD9773 Drug: Placebo |
| Enrollment | 20 |
Participant Flow
| Recruitment Details | Subjects were screened and enrolled at six centres in Japan. |
| Pre-assignment Details |
| Arm/Group Title | Dose Cohort 1 | Dose Cohort 2 | Placebo |
|---|---|---|---|
 Arm/Group Description |
AZD9773 250/50 units/kg IV | AZD9773 500/100 units/kg IV | Saline |
| Period Title: Overall Study | |||
| Started | 7 | 7 | 6 |
| Received Treatment | 7 | 7 | 6 |
| Completed Treatment | 7 [1] | 7 | 6 [2] |
| Completed | 7 [3] | 7 | 6 [4] |
| Not Completed | 0 | 0 | 0 |
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[1]
One patient died after completing the full course of study treatment.
[2]
Two patients died during the dosing period. Death was not a reason for treatment discontinuation.
[3]
One patient died during the study. Death was not a reason for treatment or study discontinuation.
[4]
Two patients died during the study. Death was not a reason for treatment or study discontinuation.
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Baseline Characteristics
| Arm/Group Title | Dose Cohort 1 | Dose Cohort 2 | Placebo | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
AZD9773 250/50 units/kg IV | AZD9773 500/100 units/kg IV | Saline | Total of all reporting groups | |
| Overall Number of Baseline Participants | 7 | 7 | 6 | 20 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 7 participants | 7 participants | 6 participants | 20 participants | |
| 71.3 (10.89) | 77.6 (10.45) | 77.7 (17.64) | 75.4 (12.78) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 7 participants | 7 participants | 6 participants | 20 participants | |
| Female |
3 42.9%
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4 57.1%
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4 66.7%
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11 55.0%
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| Male |
4 57.1%
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3 42.9%
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2 33.3%
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9 45.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Justin Lindemann |
| Organization: | AstraZeneca |
| EMail: | ClinicalTrialTransparency@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01144624 |
| Other Study ID Numbers: |
D0620C00005 |
| First Submitted: | June 7, 2010 |
| First Posted: | June 15, 2010 |
| Results First Submitted: | December 11, 2012 |
| Results First Posted: | August 22, 2013 |
| Last Update Posted: | October 6, 2014 |