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
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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 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 |

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 |
- 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
- 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
- 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

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

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
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 |
Study Director: | Justin Lindemann, MD | AstraZeneca | |
Study Director: | Wayne Dankner, MD | PAREXEL International Medical Services | |
Study Director: | Warren Botnick, MD | PAREXEL International Medical Services |
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 Posted: | June 15, 2010 Key Record Dates |
Results First Posted: | August 22, 2013 |
Last Update Posted: | October 6, 2014 |
Last Verified: | September 2014 |
TNF neutralisation |
Sepsis Toxemia Shock, Septic Shock |
Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |