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NCT Number: NCT01562457

Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII 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).

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Haemophilia A Haemophilia B Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemophilia B Hemorrhagic Disorders

Age range

16 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Lille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII

Drug

Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)

Primary outcomes

  1. TEG® (Thromboelastography) parameters after dosing of trial product

  2. ROTEM® (Thromboelastometry) parameters after dosing of trial product

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Mar 23, 2012
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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