Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State
May 11, 2016 updated by: Novo Nordisk A/S
A Randomised, Open-label, Multi-centre Trial Investigating the Intra-subject Variability of ROTEM® and TEG® Parameters Following Two Intravenous Administrations of the Same Dose of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Haemophilia Patients in a Non-bleeding State
This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state.
The TEG® parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM® parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
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.
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
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C (Activated Coagulation Factor VIIa Clotting activity) or FIX:C (Coagulation Factor IX Clotting activity) one stage activity, respectively, at less than 5% of normal (based on medical records) plus/minus inhibitors (a positive inhibitor status defined as 0.6 Bethesda units)
- Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product
Exclusion Criteria:
- Known or suspected allergy to trial product or any of its components or to related products
- Known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia A or B
- Platelet count below 50,000 platelets/mcL
- Received any haemostatic treatment (e.g. Feiba) within the last 7 days prior to administration of trial product, except for activated recombinant human factor VII
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: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: High dose
|
Administered as a single dose.
Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)
|
|
EXPERIMENTAL: Low dose
|
Administered as a single dose.
Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)
|
|
EXPERIMENTAL: Medium dose
|
Administered as a single dose.
Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
TEG® (Thromboelastography) parameters after dosing of trial product
|
|
ROTEM® (Thromboelastometry) parameters after dosing of trial product
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
TEG® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
|
|
ROTEM® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
|
|
Serious adverse events and non-serious adverse events
|
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
November 1, 2005
Primary Completion (ACTUAL)
April 1, 2006
Study Completion (ACTUAL)
April 1, 2006
Study Registration Dates
First Submitted
March 21, 2012
First Submitted That Met QC Criteria
March 22, 2012
First Posted (ESTIMATE)
March 23, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
May 12, 2016
Last Update Submitted That Met QC Criteria
May 11, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN1731-1668
- 2005-000891-42 (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.