Back to resultsBioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects
Primary Purpose
Acquired Bleeding Disorder, Acquired Haemophilia, Congenital Bleeding Disorder
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
activated recombinant human factor VII
activated recombinant human factor VII
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Bleeding Disorder
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CP-rFVIIa
VII25
Arm Description
Outcomes
Primary Outcome Measures
Area under the plasma concentration versus time curve for FVIIa clot activity
Secondary Outcome Measures
The maximum plasma concentration (Cmax)
Terminal half-life (t½)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01561417
Brief Title
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Bleeding Disorder, Acquired Haemophilia, Congenital Bleeding Disorder, Congenital FVII Deficiency, Glanzmann's Disease, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CP-rFVIIa
Arm Type
Active Comparator
Arm Title
VII25
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
One single dose administration, injected i.v. (into the vein)
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
One single dose administration, injected i.v. (into the vein)
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve for FVIIa clot activity
Secondary Outcome Measure Information:
Title
The maximum plasma concentration (Cmax)
Title
Terminal half-life (t½)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17880439
Citation
Bysted BV, Scharling B, Moller T, Hansen BL. A randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25 degrees C stable formulation. Haemophilia. 2007 Sep;13(5):527-32. doi: 10.1111/j.1365-2516.2007.01516.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects
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