Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01566786
First received: March 27, 2012
Last updated: March 29, 2012
Last verified: March 2012
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Purpose
This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) in preventing early haematoma growth in acute Intracerebral Haemorrhage (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/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomised, Double-Blind, Placebo-Controlled, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage |
Resource links provided by NLM:
Genetics Home Reference related topics:
COL4A1-related brain small-vessel disease
MedlinePlus related topics:
Bleeding Disorders
Drug Information available for:
Eptacog alfa
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Change in ICH volume as measured by CT head scans [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of adverse events [ Designated as safety issue: No ]
- Occurrence of serious adverse events [ Designated as safety issue: No ]
| Enrollment: | 48 |
| Study Start Date: | August 2001 |
| Study Completion Date: | October 2002 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: activated recombinant human factor VII |
Drug: activated recombinant human factor VII
Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult
|
| Placebo Comparator: Placebo |
Drug: placebo
Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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 in countries where waiver of informed consent is allowed by IRB/IEC, a completed waiver form
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, haemophilia or other coagulopathy, tumour, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma
- Surgical haematoma evacuation planned or performed within 24 hours of onset
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566786
Locations
| Australia | |
| Parkville, Australia, 3052 | |
| Germany | |
| Heidelberg, Germany, 60120 | |
| Italy | |
| Roma, Italy, 00185 | |
| Singapore | |
| Singapore, Singapore, 308443 | |
| Spain | |
| Girona, Spain, 17007 | |
| Taiwan | |
| Taiwan, Taiwan | |
| United Kingdom | |
| Newcastle, United Kingdom | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Nikolai C. Brun | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01566786 History of Changes |
| Other Study ID Numbers: | F7ICH-1389 |
| Study First Received: | March 27, 2012 |
| Last Updated: | March 29, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Germany: Federal Institute for Drugs and Medical Devices Italy: The Italian Medicines Agency Singapore: Health Sciences Authority Spain: Spanish Agency of Medicines Taiwan: Department of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Hemorrhage Cerebral Hemorrhage Hematologic Diseases Vascular Diseases |
Cardiovascular Diseases Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013