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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acquired Bleeding Disorder, Intracerebral Haemorrhage

In brief

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).

Key facts

Study ID

NCT01563445

Run by

Novo Nordisk A/S

People needed

40

Starts

2001-11-01

Expected to finish

2003-03-01

Last updated by the study team

2017-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Spontaneous ICH diagnosed by CT (Computerized Tomography) scanning within 3 hours of onset
• Signed informed consent form, or an exception from standard informed consent requirements

You may not qualify if…

• Time of onset of symptoms of ICH unknown or more than 3 hours prior to CT
• Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, AVM (Arteriovenous Malformation) or severe trauma
• Surgical haematoma evacuation planned or performed within 24 hours of onset

Where it is running

• Novo Nordisk Investigational Site — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.