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Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State

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ClinicalTrials.gov Identifier: NCT01562457
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia A Haemophilia B Drug: activated recombinant human factor VII Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Low dose Drug: activated recombinant human factor VII
Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)
Experimental: Medium dose Drug: activated recombinant human factor VII
Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)
Experimental: High dose Drug: activated recombinant human factor VII
Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)


Outcome Measures
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Primary Outcome Measures :
  1. TEG® (Thromboelastography) parameters after dosing of trial product
  2. ROTEM® (Thromboelastometry) parameters after dosing of trial product

Secondary Outcome Measures :
  1. TEG® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
  2. ROTEM® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
  3. Serious adverse events and non-serious adverse events

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562457


Locations
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France
Lille, France, 59037
Germany
München, Germany, 80336
Israel
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01562457    
Other Study ID Numbers: NN1731-1668
2005-000891-42 ( EudraCT Number )
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Hemostatic Disorders
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases