Clinical Trials/NCT00426803

NCT00426803CompletedPhase 2

Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Parallel Groups, Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage

Novo Nordisk A/S15 sites in 15 countries400 target enrollmentStarted: August 1, 2002Last updated: January 18, 2017

Conditions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor: Novo Nordisk A/S
Enrollment: 400
Locations: 15
Primary Endpoint: Reducing haematoma growth

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Spontaneous intracranial haemorrhage (ICH) within 3 hours after first symptom

Exclusion Criteria

•Patients with secondary ICH
•Pre-existing disability
•Haemophilia

Outcomes

Primary Outcomes

Reducing haematoma growth

Secondary Outcomes

Reducing disability and improving clinical outcome

Investigators

Sponsor

Novo Nordisk A/S

Sponsor Class

Industry

Responsible Party

Sponsor

Study Sites (15)

Loading locations...

Similar Trials

Completed

Phase 3

Recombinant Factor VIIa in Acute Intracerebral HaemorrhageAcquired Bleeding DisorderIntracerebral Haemorrhage

NCT00127283Novo Nordisk A/S829

Terminated

Phase 2

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MethotrexateInflammationRheumatoid Arthritis

NCT01636843Novo Nordisk A/S298

Terminated

Phase 2

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa BiologicsInflammationRheumatoid Arthritis

NCT01636817Novo Nordisk A/S239

Completed

Phase 2

Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain InjuryAcquired Bleeding DisorderTrauma

NCT00123591Novo Nordisk A/S96

Completed

Phase 2

Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral HaemorrhageAcquired Bleeding DisorderIntracerebral Haemorrhage

NCT01566786Novo Nordisk A/S48