CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
AZD9773 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01144624
NCT01144624Phase 2Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Jun 15, 2010·Updated Oct 6, 2014

In Brief

A Phase 2 clinical trial evaluating AZD9773 and Placebo for Severe Sepsis and Septic Shock. Completed, enrolled 20 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Sepsis, Septic Shock
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 15, 2010
Enrollment StartJul 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.0 years ago

Interventions

AZD9773drug

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

Placebodrug

Intravenous infusion of a saline solution