Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01563445
First received: March 23, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Acquired Bleeding Disorder Intracerebral Haemorrhage |
Drug: activated recombinant human factor VII Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
COL4A1-related brain small-vessel disease
MedlinePlus related topics:
Bleeding
Drug Information available for:
Eptacog alfa (activated)
U.S. FDA Resources
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- Occurrence of a treatment-related serious adverse event (SAE) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of adverse events [ Designated as safety issue: No ]
- Change in ICH volume as measured by CT head scans [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | November 2001 |
| Study Completion Date: | March 2003 |
| Primary Completion Date: | March 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563445
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563445
Locations
| United States, New York | |
| Novo Nordisk Clinical Trial Call Center | |
| New York, New York, United States, 10032 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Nikolai C. Brun | Novo Nordisk A/S |
More Information
Additional Information:
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01563445 History of Changes |
| Other Study ID Numbers: | F7ICH-2073 |
| Study First Received: | March 23, 2012 |
| Last Updated: | March 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hemorrhage Cerebral Hemorrhage Hematoma Blood Coagulation Disorders Hemostatic Disorders Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Hematologic Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on September 23, 2016