Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage
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ClinicalTrials.gov Identifier: NCT01563445 |
Recruitment Status :
Completed
First Posted : March 27, 2012
Last Update Posted : January 13, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acquired Bleeding Disorder Intracerebral Haemorrhage | Drug: activated recombinant human factor VII Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Study Start Date : | November 2001 |
Actual Primary Completion Date : | March 2003 |
Actual Study Completion Date : | March 2003 |

Arm | Intervention/treatment |
---|---|
Experimental: activated recombinant human factor VII |
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 Comparator: Placebo |
Drug: placebo
Subjects will be randomised to receive a single intravenous dose. Administered within the first 4 hours after the insult |
- Occurrence of a treatment-related serious adverse event (SAE)
- Occurrence of adverse events
- Change in ICH volume as measured by CT head scans

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563445
United States, New York | |
Novo Nordisk Investigational Site | |
New York, New York, United States, 10032 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Publications of Results:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01563445 |
Other Study ID Numbers: |
F7ICH-2073 |
First Posted: | March 27, 2012 Key Record Dates |
Last Update Posted: | January 13, 2017 |
Last Verified: | January 2017 |
Cerebral Hemorrhage Hemostatic Disorders Blood Coagulation Disorders Hemorrhage Hematoma Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Hematologic Diseases Hemorrhagic Disorders |