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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 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
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
Hide 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
[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.
Arm/Group Title Dose Cohort 1 Dose Cohort 2 Placebo Total
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 6 participants 20 participants
Female
3
  42.9%
4
  57.1%
4
  66.7%
11
  55.0%
Male
4
  57.1%
3
  42.9%
2
  33.3%
9
  45.0%
1.Primary Outcome
Title Safety and Tolerability of AZD9773
Hide Description Number of patients with treatment-emergent adverse events and number of patients who died over 28 days
Time Frame 28 day study period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Arm 1 - Dose Cohort 1 Arm 2 - Dose Cohort 2 Arm 3 - Placebo
Hide Arm/Group Description:
AZD9773 250/50 units/kg IV
AZD9773 500/100 units/kg IV
Saline
Overall Number of Participants Analyzed 7 7 6
Measure Type: Number
Unit of Measure: Participants
Number of Patients with Treatment-Emergent AEs 7 7 6
Number of Patients who Died over 28 days 1 0 2
2.Primary Outcome
Title Pharmacokinetics of AZD9773
Hide Description Maximum concentration at steady state (Cmax ss) for serum total and specific fabs
Time Frame From first dose to last dose (Day 5/6 or at premature treatment discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set
Arm/Group Title Arm 1 - Dose Cohort 1 Arm 2 - Dose Cohort 2 Arm 3 - Placebo
Hide Arm/Group Description:
AZD9773 250/50 units/kg IV
AZD9773 500/100 units/kg IV
Saline
Overall Number of Participants Analyzed 7 5 0
Geometric Mean (Full Range)
Unit of Measure: ug/mL
Cmax ss for serum total fabs
38.48
(30.5 to 62.4)
71.04
(41.7 to 90.7)
Cmax ss for serum specific fabs
1.823
(1.31 to 2.62)
3.335
(1.92 to 4.62)
3.Secondary Outcome
Title Pharmacodynamic Effects of AZD9773 on TNF-alpha
Hide Description TNF-alpha levels over approximately 6 days following the first dose
Time Frame Levels taken at baseline, over the dosing period (up to Day 5/6)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Arm 1 - Dose Cohort 1 Arm 2 - Dose Cohort 2 Arm 3 - Placebo
Hide Arm/Group Description:
AZD9773 250/50 units/kg IV
AZD9773 500/100 units/kg IV
Saline
Overall Number of Participants Analyzed 7 7 6
Median (Full Range)
Unit of Measure: pg/ml
TNF-alpha level at baseline
1.000
(0.92 to 8.89)
1.690
(0.92 to 2.65)
8.810
(1.13 to 29.17)
TNF-alpha level 1-2 hours post-first dose
0.920
(0.92 to 5.93)
0.990
(0.92 to 2.18)
7.425
(0.92 to 28.40)
TNF-alpha level on Day 6 (pre-morning dose)
1.710
(0.92 to 14.90)
1.140
(0.92 to 1.57)
1.560
(0.92 to 3.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose Cohort 1 Dose Cohort 2 Placebo
Hide Arm/Group Description AZD9773 250/50 units/kg IV AZD9773 500/100 units/kg IV Saline
All-Cause Mortality
Dose Cohort 1 Dose Cohort 2 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Dose Cohort 1 Dose Cohort 2 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/7 (57.14%)   1/7 (14.29%)   1/6 (16.67%) 
Cardiac disorders       
Acute Myocardial Infarction  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Ventricular Tachycardia  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders       
Large Intestine Perforation  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Gastric Cancer  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Nervous system disorders       
Cerebral Infarction  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Parkinsonism  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Haemothorax  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose Cohort 1 Dose Cohort 2 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   7/7 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders       
Anaemia  1  2/7 (28.57%)  1/7 (14.29%)  0/6 (0.00%) 
Haemorrhagic Anaemia  1  1/7 (14.29%)  1/7 (14.29%)  0/6 (0.00%) 
Cardiac disorders       
Arrhythmia  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Atrial Fibrillation  1  0/7 (0.00%)  2/7 (28.57%)  0/6 (0.00%) 
Bradycardia  1  1/7 (14.29%)  1/7 (14.29%)  0/6 (0.00%) 
Cardiovascular Insufficiency  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Mitral Valve Incompetence  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Sinus Tachycardia  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Supraventricular Extrasystoles  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Ventricular Extrasystoles  1  1/7 (14.29%)  2/7 (28.57%)  1/6 (16.67%) 
Ventricular Tachycardia  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Congenital, familial and genetic disorders       
Pyloric Stenosis  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Endocrine disorders       
Adrenal Insufficiency  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Eye disorders       
Conjunctival Hyperaemia  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Conjunctival Oedema  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Gastrointestinal disorders       
Abdominal Compartment Syndrome  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Anal Erosion  1  2/7 (28.57%)  0/7 (0.00%)  0/6 (0.00%) 
Ascites  1  0/7 (0.00%)  2/7 (28.57%)  0/6 (0.00%) 
Cheilitis  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Colitis  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Constipation  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Diarrhoea  1  1/7 (14.29%)  1/7 (14.29%)  3/6 (50.00%) 
Gastric Haemorrhage  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Gastritis Erosive  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Gastrointestinal Haemorrhage  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Gastrointestinal Hypomotility  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Haematochezia  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Ileus Paralytic  1  1/7 (14.29%)  2/7 (28.57%)  0/6 (0.00%) 
Periodontitis  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Stomatitis  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Vomiting  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
General disorders       
Catheter Site Haematoma  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Device Leakage  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Disuse Syndrome  1  2/7 (28.57%)  1/7 (14.29%)  1/6 (16.67%) 
Fat Necrosis  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Generalised Oedema  1  2/7 (28.57%)  0/7 (0.00%)  0/6 (0.00%) 
Injection Site Erythema  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Oedema  1  1/7 (14.29%)  2/7 (28.57%)  0/6 (0.00%) 
Oedema Peripheral  1  1/7 (14.29%)  3/7 (42.86%)  0/6 (0.00%) 
Pain  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Hepatic Function Abnormal  1  2/7 (28.57%)  0/7 (0.00%)  1/6 (16.67%) 
Jaundice  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Infections and infestations       
Abdominal Abscess  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Bacteraemia  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Cellulitis Staphylococcal  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Colostomy Infection  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Fungaemia  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Fungal Skin Infection  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Herpes Zoster  1  1/7 (14.29%)  1/7 (14.29%)  0/6 (0.00%) 
Incision Site Cellulitis  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Infectious Peritonitis  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Oral Herpes  1  1/7 (14.29%)  1/7 (14.29%)  1/6 (16.67%) 
Pneumonia  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Pneumonia Bacterial  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Pneumonia Pneumococcal  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Pneumonia Staphylococcal  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Postoperative Wound Infection  1  2/7 (28.57%)  0/7 (0.00%)  2/6 (33.33%) 
Pseudomembranous Colitis  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Septic Shock  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Tinea Cruris  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Tracheostomy Infection  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Urinary Tract Infection  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Injury, poisoning and procedural complications       
Gastrointestinal Anastomotic Leak  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Incision Site Haemorrhage  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Post Procedural Complication  1  1/7 (14.29%)  1/7 (14.29%)  0/6 (0.00%) 
Post Procedural Haemorrhage  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Tracheal Obstruction  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Traumatic Lung Injury  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Wound Complication  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Investigations       
Blood Creatine Phosphokinase Increased  1  1/7 (14.29%)  1/7 (14.29%)  0/6 (0.00%) 
Blood Pressure Decreased  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Body Temperature Increased  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
C-Reactive Protein Increased  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Heart Rate Increased  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Hepatic Enzyme Increased  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Pancreatic Enzymes Increased  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Urine Output Decreased  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
White Blood Cell Count Decreased  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Metabolism and nutrition disorders       
Acidosis  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Gout  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Hyperglycaemia  1  1/7 (14.29%)  0/7 (0.00%)  1/6 (16.67%) 
Hyperkalaemia  1  1/7 (14.29%)  0/7 (0.00%)  1/6 (16.67%) 
Hypoalbuminaemia  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Hypokalaemia  1  1/7 (14.29%)  1/7 (14.29%)  0/6 (0.00%) 
Hyponatraemia  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Hypovolaemia  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Metabolic Alkalosis  1  2/7 (28.57%)  0/7 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders       
Muscular Weakness  1  1/7 (14.29%)  0/7 (0.00%)  1/6 (16.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Gastric Cancer  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Psychiatric disorders       
Delirium  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Insomnia  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Mental Disorder Due To A General Medical Condition  1  2/7 (28.57%)  0/7 (0.00%)  1/6 (16.67%) 
Renal and urinary disorders       
Renal Impairment  1  0/7 (0.00%)  2/7 (28.57%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Atelectasis  1  0/7 (0.00%)  2/7 (28.57%)  0/6 (0.00%) 
Dyspnoea  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Haemoptysis  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Oropharyngeal Pain  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Pleural Effusion  1  5/7 (71.43%)  4/7 (57.14%)  0/6 (0.00%) 
Pneumomediastinum  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Pneumonia Aspiration  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Pneumothorax  1  1/7 (14.29%)  1/7 (14.29%)  0/6 (0.00%) 
Productive Cough  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Pulmonary Congestion  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Pulmonary Fibrosis  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Tachypnoea  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Tracheal Oedema  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Vocal Cord Polyp  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Wheezing  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders       
Decubitus Ulcer  1  1/7 (14.29%)  0/7 (0.00%)  1/6 (16.67%) 
Dermatitis  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Dermatitis Contact  1  1/7 (14.29%)  1/7 (14.29%)  1/6 (16.67%) 
Dry Skin  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Erythema  1  3/7 (42.86%)  0/7 (0.00%)  1/6 (16.67%) 
Petechiae  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Purpura  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Rash  1  0/7 (0.00%)  1/7 (14.29%)  1/6 (16.67%) 
Skin Erosion  1  1/7 (14.29%)  1/7 (14.29%)  0/6 (0.00%) 
Skin Exfoliation  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Skin Haemorrhage  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Skin Oedema  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Subcutaneous Emphysema  1  2/7 (28.57%)  1/7 (14.29%)  0/6 (0.00%) 
Vascular Purpura  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Surgical and medical procedures       
Dermabrasion  1  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Vascular disorders       
Flushing  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Hypertension  1  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Jugular Vein Thrombosis  1  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Justin Lindemann
Organization: AstraZeneca
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
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