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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Factor VIII

Criteria

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