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Randomized double-blind placebo-controlled dose-escalation Phase 2 trial of rFVIIa (NovoSeven) for postoperative bleeding after cardiopulmonary bypass cardiac surgery

2004-000100-40Phase 2Completed

Sponsor
Novo Nordisk
Start
Jun 2004
Modality
Recombinant Proteins and Enzymes
Countries
1
01

Overview

Phase 2, randomised, double-blind trial in postoperative hemorrhage comparing NovoSeven (rFVIIa) arm with Placebo arm (2 arms). Primary endpoint: Serious and critical adverse events. Started Jun 2004; status: completed.

02

Drugs

coagulation factor VIIa
03

Conditions

postoperative hemorrhage

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