Factor VIIa in Acute Intracerebral Haemorrhage

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Intracerebral Haemorrhage; Acquired Bleeding Disorder

Treatments: Drug: eptacog alfa (activated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00266006

JapicCTI-050194 (Registry Identifier)

F7ICH-1602

Details and patient eligibility

About

This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute intracerebral haemorrhage.

Enrollment: 90 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spontaneous ICH

Exclusion criteria

• Time of ICH onset > 3 hours
• Patients with secondary ICH
• Pre-existing disability
• Hemophilia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind