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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01562457
First received: March 21, 2012
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Drug: activated recombinant human factor VII
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • TEG® (Thromboelastography) parameters after dosing of trial product [ Designated as safety issue: No ]
  • ROTEM® (Thromboelastometry) parameters after dosing of trial product [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TEG® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII [ Designated as safety issue: No ]
  • ROTEM® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII [ Designated as safety issue: No ]
  • Serious adverse events and non-serious adverse events [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562457

Locations
France
Lille, France, 59037
Germany
München, Germany, 80336
Israel
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Anita Borup Helboe Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01562457     History of Changes
Other Study ID Numbers: NN1731-1668, 2005-000891-42
Study First Received: March 21, 2012
Last Updated: July 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemophilia B
Hemophilia A
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014