Sepsis Clinical Trial
Official title:
A Pivotal, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety of TAK-242 in Adults With Severe Sepsis
The purpose of this study is to determine the optimal dose of Resatorvid for reducing 28-day all-cause mortality in subjects with severe sepsis.
Severe sepsis, defined as sepsis associated with acute organ dysfunction, remains a serious
medical problem worldwide. In the United States alone, approximately 750,000 cases of severe
sepsis occur each year, with the mortality rate ranging between 30% and 50% for severe
sepsis patients with concomitant organ dysfunction. As the population ages, these numbers
are expected to increase. The pathophysiology of severe sepsis is thought to involve the
activation of a variety of inflammatory and procoagulant host responses to infection, which
if unchecked, can lead to diffuse endovascular injury, multi-organ dysfunction, and
ultimately death.
The host response to infection with microorganism and microorganism-derived molecules is
characterized by the synthesis and release of pro-inflammatory cytokines such as tumor
necrosis factor-alpha (TNF-α) and interleukins 1, 6 and 8 (IL-1, IL-6, and IL-8), by
inflammatory cells, and by other markers of inflammation such as C-reactive protein.
Inflammatory cells, such as macrophages, release these cytokines by signals transmitted from
the surface of these cells after binding of pathogen-associated molecules to cell surface
pattern recognition receptors known as toll-like receptors.
TAK-242 (resatorvid) is a small molecule suppressor of pathogen-induced release of
inflammatory cytokines and acts by inhibiting TLR-4 mediated signaling. Because of its
inhibitory effect on suppressing cytokine levels, resatorvid is being developed as a
treatment for severe sepsis.
The study was ended after the DSMB determined there was insufficient cytokine suppression in
the 150-subject analysis within Stage 1 of the study.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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|---|---|---|---|
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