- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01561417
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects
January 18, 2017 updated by: Novo Nordisk A/S
A Single-centre, Randomised, Double-blind, Two-way Cross-over Trial Investigating the Bio-equivalence in Healthy Male Subjects of NovoSeven (CP-rFVIIa) and a Formulation of NovoSeven Stable at 25°C (VII25)
This trial is conducted in Europe.
The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75015
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Caucasian
- Body Mass Index (BMI) between 18 and 27 kg/m^2, both inclusive
- Good health as indicated by medical history, physical examination including vital signs and ECG, and clinical laboratory test results
- Smoke less than 10 cigarettes (or equivalent) per day
- Capable of giving written Informed Consent (IC)
Exclusion Criteria:
- Evidence of clinically relevant pathology or potential thromboembolic risk based on medical and/or family history as judged by the Investigator
- Known history of atherosclerosis, arteriosclerosis, thromboembolic events or known high levels of Troponin I
- Known or suspected allergy to activated recombinant human factor VII or related products or any of the components of the formulation
- Overt bleeding, including from gastrointestinal tract
- Hepatitis (B or C) infection
- HIV (human immunodeficiency virus) infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CP-rFVIIa
|
One single dose administration, injected i.v.
(into the vein)
|
Experimental: VII25
|
One single dose administration, injected i.v.
(into the vein)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Area under the plasma concentration versus time curve for FVIIa clot activity
|
Secondary Outcome Measures
Outcome Measure |
---|
The maximum plasma concentration (Cmax)
|
Terminal half-life (t½)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
September 1, 2006
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
March 21, 2012
First Submitted That Met QC Criteria
March 21, 2012
First Posted (Estimate)
March 23, 2012
Study Record Updates
Last Update Posted (Estimate)
January 19, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Hematologic Diseases
- Blood Coagulation Disorders, Inherited
- Coagulation Protein Disorders
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Hemostatic Disorders
- Hemophilia A
- Hemophilia B
- Blood Coagulation Disorders
- Disease
- Hemorrhage
- Hemorrhagic Disorders
Other Study ID Numbers
- NN1007-1744
- 2005-005379-14 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on activated recombinant human factor VII
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Novo Nordisk A/SCompletedTrauma | Acquired Bleeding DisorderUnited States, Canada
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Novo Nordisk A/SCompletedAcquired Bleeding Disorder | Intracerebral HaemorrhageSpain, Sweden, Singapore, Norway, Italy, Switzerland, Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Netherlands, United Kingdom
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Novo Nordisk A/SCompletedHealthy | Congenital Bleeding DisorderUnited States
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Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A | Haemophilia BFrance, Israel, Germany
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Novo Nordisk A/SCompletedOther Haemostasis Disorder | Haemorrhagic CystitisUnited States
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Novo Nordisk A/STerminatedAcquired Bleeding Disorder | Cardiac Surgery Requiring Cardiopulmonary BypassUnited States, Spain, Germany, Sweden, United Kingdom, Argentina, Italy, Brazil, Denmark, France, India, Malaysia, Singapore, South Africa
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With InhibitorsFrance, United Kingdom, Spain, Israel, Poland, Turkey, Hungary
-
Novo Nordisk A/SCompletedObservational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII DeficiencyCongenital Bleeding Disorder | Congenital FVII DeficiencyJapan
-
Novo Nordisk A/SCompletedCirrhosis | Acquired Bleeding DisorderGermany, United Kingdom, Spain, Taiwan, France, Italy, Austria, Czech Republic, Poland, Denmark, Finland, Hong Kong
-
Novo Nordisk A/SCompletedTrauma | Acquired Bleeding DisorderIndia, Spain, Canada, Finland, Germany, Israel, Italy, Netherlands, Singapore, Switzerland, Taiwan