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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01563445
Other study ID # F7ICH-2073
Secondary ID
Status Completed
Phase Phase 2
First received March 23, 2012
Last updated January 12, 2017
Start date November 2001
Est. completion date March 2003

Study information

Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2003
Est. primary completion date March 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Intervention

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
placebo
Subjects will be randomised to receive a single intravenous dose. Administered within the first 4 hours after the insult

Locations

Country Name City State
United States Novo Nordisk Investigational Site New York New York

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (3)

Diringer MN, Skolnick BE, Mayer SA, Steiner T, Davis SM, Brun NC, Broderick JP. Risk of thromboembolic events in controlled trials of rFVIIa in spontaneous intracerebral hemorrhage. Stroke. 2008 Mar;39(3):850-6. doi: 10.1161/STROKEAHA.107.493601. — View Citation

Mayer SA, Brun NC, Broderick J, Davis SM, Diringer MN, Skolnick BE, Steiner T; United States NovoSeven ICH Trial Investigators.. Recombinant activated factor VII for acute intracerebral hemorrhage: US phase IIA trial. Neurocrit Care. 2006;4(3):206-14. — View Citation

Mayer SA, Brun NC, Broderick J, Diringer MN, Davis SM, Steiner T. Safety and Preliminary Efficacy of Recombinant Coagulation Factor VII in Patients with Acute Intracerebral Hemorrhage. Stroke 2004; 35: 322

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of a treatment-related serious adverse event (SAE)
Secondary Occurrence of adverse events
Secondary Change in ICH volume as measured by CT head scans
See also
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Completed NCT00124293 - Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury N/A
Terminated NCT00184548 - Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Phase 3
Completed NCT02239146 - Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass Phase 1
Withdrawn NCT00323570 - Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma Phase 3
Completed NCT00127283 - Recombinant Factor VIIa in Acute Intracerebral Haemorrhage Phase 3
Completed NCT01563523 - Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients Phase 2
Terminated NCT01564563 - Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation Phase 2
Completed NCT01153997 - Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers Phase 1
Completed NCT00697320 - Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany N/A
Completed NCT00914589 - Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery Phase 2
Completed NCT00102037 - Use of Activated Recombinant FVII in Spinal Surgery Phase 2
Completed NCT01601613 - Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever Phase 2
Completed NCT01562821 - Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy Phase 2
Completed NCT00266006 - Factor VIIa in Acute Intracerebral Haemorrhage Phase 2
Completed NCT00123591 - Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury Phase 2
Completed NCT01562574 - Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease Phase 3
Completed NCT01285089 - Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia N/A
Terminated NCT00154427 - Use of Activated Recombinant Human Factor VII in Cardiac Surgery Phase 2
Completed NCT00426803 - Recombinant Factor VIIa in Acute Intracerebral Haemorrhage Phase 2