NCT01563445

Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage

Multi-center, Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of Activated Recombinant Factor VII (NovoSeven®) for Preventing Early Hematoma Growth in Acute Intracerebral Hemorrhage (ICH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) for preventing early hematoma growth in acute Intracerebral Hemorrhage (ICH).

Conditions

• Acquired Bleeding Disorder
• Intracerebral Haemorrhage

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII	Subjects will be randomised to receive a single intravenous dose of either 5, 20, 40 and 80 mcg/kg body weight. Administered within the first 4 hours after the insult
DRUG	placebo	Subjects will be randomised to receive a single intravenous dose. Administered within the first 4 hours after the insult

Timeline

• Start date: 2001-11-01
• Primary completion: 2003-03-01
• Completion: 2003-03-01
• First posted: 2012-03-27
• Last updated: 2017-01-13

Locations

1 site across 1 country: United States