Principal Investigators:
Chaim Lotan MD, Dan AdmonMD, Bilha Kreisberg RN

Sponsor
Wyeth Ayerst

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Abstract

This is a phase II/III, randomized, double-blind, placebo-controlled, multi-center trial of the efficacy and safety of soluble recombinant human TNF receptor Fc fusion protein (etanercept/TNR-001) in patients with congestive heart failure (Class II-IV).
The primary objectives are to evaluate the efficacy of two dosing regimens of TNR-001 and placebo subcutaneous injections in patients with New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF). Efficacy evaluation will be by
1. A clinical composite score, measured at the end of 24 weeks, which takes into account the NYHA class, patient global assessment of CHF and death, and
2. Combined all cause mortality and CHF morbidity (CHF hospitalization).

The secondary objectives are to compare two dosing regimens of TNR-001 and placebo subcutaneous injections in patients with Class II-IV CHF by assessing all-cause mortality, objective laboratory measures, questionnaires, safety of TNR-001, health outcome assessment/pharmacoeconomic impact on medical resource use and pharmacokinetics. In addition the study will describe the pharmacokinetics of etanercept in patients with CHF. An effort will also be made to investigate the phamacodynamic relationship between etanercept concentrations and outcome measurements observed in the study.

Status
Ongoing trial

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