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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Haemophilia B With Inhibitors; Haemophilia A With Inhibitors; Congenital Bleeding Disorder

Treatments: Drug: eptacog alfa (activated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01561924

F7HAEM-1675

Details and patient eligibility

About

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.

Full 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)

Enrollment: 17 patients

Sex: Male

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Ex vivo

Experimental group

Treatment:

Drug: eptacog alfa (activated)