Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography

Congenital Bleeding Disorder Clinical Trial

Official title:

An Exploratory Non-interventional Study of Ex-vivo Spiking Followed by Thromboelastography as a Method for Predicting the Efficacy of Recombinant Activated Human FVII (rFVIIa, NovoSeven®) in Adult Congenital Haemophilia A or B Patients With Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561924
• Other study ID #: F7HAEM-1675
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2012
• Last updated: November 22, 2016
• Start date: November 2005
• Est. completion date: May 2006

Study information

• Verified date: November 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM® (Thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in a non-bleeding state.

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C clot activity or FIX:C clot activity, respectively, less than 5%

• Presently use of activated recombinant human factor VII (NovoSeven®) as haemostatic agent for preventive treatment or treatment of bleeding episodes

• A documented historical or present record for the presence of inhibitors to factor VIII or IX, respectively

• A documented history of 2 or more joint bleeding episodes during the preceding 12 months

• Subjects must be in a non-bleeding state (i.e. no clinical manifestations of active bleeds)

Exclusion Criteria:

• Subjects who have received any haemostatic treatment for a bleeding episode within the last 7 days prior to this trial

• Immune tolerance therapy within the last 30 days prior to this trial

• Clinically relevant coagulation disorders other than congenital haemophilia A or B

• Thrombocytopenia (platelet count below 60,000 platelets/mcl)

• Prophylactic haemostatic treatment within 3 days prior to this trial

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A With Inhibitors
• Haemophilia B With Inhibitors
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders

Intervention

Drug:
• eptacog alfa (activated)
Subjects will be called to attend the clinic in a non-bleeding state. Blood samples will be drawn for thromboelastogram profiling and will be in-vitro spiked with different doses of activatated recombinant human factor VII.

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Århus N
France	Novo Nordisk Investigational Site	Lyon
United Kingdom	Novo Nordisk Investigational Site	London
United States	Novo Nordisk Investigational Site	Berkeley	California
United States	Novo Nordisk Investigational Site	Iowa City	Iowa
United States	Novo Nordisk Investigational Site	Los Angeles	California
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Denmark,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEG parameters obtained at baseline and with activated recombinant human factor VII			No
Primary	ROTEM parameters obtained at baseline and with activated recombinant human factor VII			No

External Links

•   Clinical Trials at Novo Nordisk