A Phase 2, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous Infusions of AZD9773 in Japanese Patients With Severe Sepsis and/or Septic Shock

Phase 2

• Conditions: Severe Sepsis, Septic Shock

• Registration Number: JPRN-jRCT2080221164
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

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 or less).

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 microL.

6. High dose steroids or other immunocompromising drugs.

-Concomitant diseases:

1. Deep-seated fungal infection or active tuberculosis.

2. Server chronic liver disease associated with portal hypertension, cirrhosis, Choric 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified