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

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors
• Interventions: Drug: eptacog alfa (activated)

• Registration Number: NCT01561924
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed 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)

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ex vivo	eptacog alfa (activated)	-

Primary Outcome Measures

Name	Time	Method
ROTEM parameters obtained at baseline and with activated recombinant human factor VII
TEG parameters obtained at baseline and with activated recombinant human factor VII

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 London, United Kingdom