Back to resultsSafety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers
Primary Purpose
Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
activated recombinant human factor VII
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Bleeding Disorder
Eligibility Criteria
Inclusion Criteria:
- Caucasian or Japanese
- Healthy as defined by medical history, physical and biological examinations
Exclusion Criteria:
- History of allergy or hypersensitivity reaction to any medication
- History or presence of any organic disorder likely to modify absorption, distribution or elimination of the medication
- Alcohol or substance abuse disorder
- Subject in his exclusion period in the Healthy Volunteers National Register of the French Ministry of Health
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Treatment sequence 1
Treatment sequence 2
Treatment sequence 3
Treatment sequence 4
Arm Description
Outcomes
Primary Outcome Measures
Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours
Secondary Outcome Measures
Mean residence time (MRT)
Maximum plasma concentration (Cmax)
Time to reach maximum plasma concentration (tmax)
Area under the Curve (AUC) from 0-24 hours of the PT (Prothrombin Time)
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01563471
Brief Title
Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers
Official Title
Single-centre, Randomised, Placebo-controlled, Double-blind, Dose Escalation Trial Investigating Pharmacokinetics, Pharmacodynamics and Tolerability of Three Different Single Intravenous Doses of Activated Recombinant Factor VIIa (rFVIIa/NovoSeven®) in Healthy Caucasian and Japanese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
July 2002 (Actual)
Study Completion Date
July 2002 (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 investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Bleeding Disorder, 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
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment sequence 1
Arm Type
Experimental
Arm Title
Treatment sequence 2
Arm Type
Experimental
Arm Title
Treatment sequence 3
Arm Type
Experimental
Arm Title
Treatment sequence 4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits
Primary Outcome Measure Information:
Title
Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours
Secondary Outcome Measure Information:
Title
Mean residence time (MRT)
Title
Maximum plasma concentration (Cmax)
Title
Time to reach maximum plasma concentration (tmax)
Title
Area under the Curve (AUC) from 0-24 hours of the PT (Prothrombin Time)
Title
Adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Caucasian or Japanese
Healthy as defined by medical history, physical and biological examinations
Exclusion Criteria:
History of allergy or hypersensitivity reaction to any medication
History or presence of any organic disorder likely to modify absorption, distribution or elimination of the medication
Alcohol or substance abuse disorder
Subject in his exclusion period in the Healthy Volunteers National Register of the French Ministry of Health
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
15870545
Citation
Fridberg MJ, Hedner U, Roberts HR, Erhardtsen E. A study of the pharmacokinetics and safety of recombinant activated factor VII in healthy Caucasian and Japanese subjects. Blood Coagul Fibrinolysis. 2005 Jun;16(4):259-66. doi: 10.1097/01.mbc.0000169218.15926.34.
Results Reference
result
PubMed Identifier
16734808
Citation
Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919-33. doi: 10.1111/j.1537-2995.2006.00824.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers
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