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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Severe Sepsis Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

AZD9773

Intervention Type DRUG

A single loading dose followed by 9 maintenance doses; doses to be given every 12 hours over a period of 5 days

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravenous infusion of a saline solution

Interventions

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AZD9773

A single loading dose followed by 9 maintenance doses; doses to be given every 12 hours over a period of 5 days

Intervention Type DRUG

Placebo

Intravenous infusion of a saline solution

Intervention Type DRUG

Other Intervention Names

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CytoFab™

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No