AZD9773 Dose Escalation Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00615017
• Date of registration: 31/01/2008
• Primary sponsor: AstraZeneca
• Public title: AZD9773 Dose Escalation Study
• Scientific title: A Placebo-controlled, Double-blind, Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of Single and Multiple Intravenous Infusions of CytoFab (AZD9773) in Patients With Severe Sepsis
• Date of first enrolment: January 2008
• Target sample size: 73
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00615017
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Steven Simonson, MD
• Affiliation: AstraZeneca

• Name: Wayne Dankner, MD
• Affiliation: Parexel

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical evidence of infection requiring treatment with parenteral antibiotics

- Patients must meet multiple SIRS criteria

- Patients must meet criteria for cardiovascular and/or respiratory dysfunction

- Sepsis (infection plus SIRS criteria) must be present prior to organ dysfunction

Exclusion Criteria:

- Moribund and death is considered imminent, or patient not expected to survive 90 days
because of underlying medical condition, or classified as Do Not Resuscitate or Do
Not Treat

- Patient cannot attain a MAP >60 mmHg when measured via an arterial line and/or a SBP
>80 mmHg in the presence of vasopressors and iv fluids for a period of =2 hours

- Receiving immunosuppressants, or high dose steroids within 2 months of provision of
informed consent

- Any history of hypersensitivity reaction to sheep products, latex, papain or papaya,
or chymopapain or previously administered antivenom manufactured using ovine serum,
digoxin immune fab (DigiFab™ , DIGIBIND® ), crotalidae polyvalent immune fab (ovine)
(CroFab™ ), or other sheep derived product.

- Treatment with anti-TNF antibodies within 8 weeks before provision of written
informed consent.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Severe Sepsis

Intervention(s)

Drug: AZD9773 (CytoFab)

Secondary ID(s)

D0620C00004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors