Phase 2
N=20
A Study to Assess Safety,and Tolerability of 2 Doses of AZD9773 (CytoFab™) in Japanese With Severe Sepsis/Septic Shock
Severe Sepsis · Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT01144624 ↗Enrolled (actual)
20
Serious AEs
30.0%
Results posted
Aug 2013
Primary outcome: Primary: Safety and Tolerability of AZD9773 — 7; 7; 6; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD9773 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of AZD9773 |
7; 7; 6; 1; 0; 2 | — |
| PRIMARY Pharmacokinetics of AZD9773 |
38.48; 71.04; 1.823; 3.335 | — |
| SECONDARY Pharmacodynamic Effects of AZD9773 on TNF-alpha |
1.000; 1.690; 8.810; 0.920; 0.990; 7.425 | — |
Summary
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.
Eligibility Criteria
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:
- 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 30% of body surface area in the past 5 days.
- 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.
Data sourced from ClinicalTrials.gov (NCT01144624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.