Back to resultsA Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors
Primary Purpose
Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
eptacog alfa (activated)
eptacog alfa (activated)
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Bleeding Disorder
Eligibility Criteria
Inclusion Criteria:
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Male patients with confirmed diagnosis of severe congenital haemophilia A or B (higher than 1% FVIII or FIX) with or without inhibitors to coagulation factors VIII or IX, based on medical records
Exclusion Criteria:
- Congenital or acquired coagulation disorder other than congenital haemophilia A or B
- Any clinical signs or known history of arterial thrombotic events or previous deep vein thrombosis or pulmonary embolism (as defined by available medical records)
- Use of any anticoagulant (e.g. un-fractionated or low molecular weight heparin, vitamin-K antagonists, direct thrombin inhibitors or factor Xa inhibitors)
- Bleeding prophylactic treatment or FVIII or FIX immune tolerance induction (ITI) treatment during the trial period
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
270 microg/kg rFVIIa
3x90 microg/kg rFVIIa
Arm Description
Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours
Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours
Outcomes
Primary Outcome Measures
Thromboelastography (TEG) parameter Maximum Thrombosis Generation (MTG;'maximum velocity')
Secondary Outcome Measures
TEG parameters r-time, MTG, alpha angle, and maximum amplitude (MA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01949792
Brief Title
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors
Official Title
An Open-label Single- and Multiple-dose Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa Following i.v. Administration of One Dose of 270 Microg/kg and Three Doses of 90 Microg/kg in Patients With Haemophilia A or B With or Without Inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (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 the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII) following one single injection of 270 microg/kg compared to three injections of 90 microg/kg rFVIIa in patients with haemophilia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
270 microg/kg rFVIIa
Arm Type
Active Comparator
Arm Description
Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours
Arm Title
3x90 microg/kg rFVIIa
Arm Type
Active Comparator
Arm Description
Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours
Intervention Type
Drug
Intervention Name(s)
eptacog alfa (activated)
Intervention Description
Subject will receive a single injection (i.v.) of 270 microg/kg rFVIIa (NovoSeven®)
Intervention Type
Drug
Intervention Name(s)
eptacog alfa (activated)
Intervention Description
Subject will receive 3 injections (i.v.) of 90 microg/kg rFVIIa (NovoSeven®) over a 6 hour period (each injection will be separated by 3 hours)
Primary Outcome Measure Information:
Title
Thromboelastography (TEG) parameter Maximum Thrombosis Generation (MTG;'maximum velocity')
Time Frame
10 minutes post-dose for 270 microg/kg and 10 minutes after the first injection of 90 microg/kg
Secondary Outcome Measure Information:
Title
TEG parameters r-time, MTG, alpha angle, and maximum amplitude (MA)
Time Frame
Prior to and 24 hours following the administrtion of 270 microg/kg and each of the 3 administrations of 90 microg/kg
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male patients with confirmed diagnosis of severe congenital haemophilia A or B (higher than 1% FVIII or FIX) with or without inhibitors to coagulation factors VIII or IX, based on medical records
Exclusion Criteria:
Congenital or acquired coagulation disorder other than congenital haemophilia A or B
Any clinical signs or known history of arterial thrombotic events or previous deep vein thrombosis or pulmonary embolism (as defined by available medical records)
Use of any anticoagulant (e.g. un-fractionated or low molecular weight heparin, vitamin-K antagonists, direct thrombin inhibitors or factor Xa inhibitors)
Bleeding prophylactic treatment or FVIII or FIX immune tolerance induction (ITI) treatment during the trial period
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:
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors
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