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

Completed · Phase 1

Conditions studied: Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

In brief

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.

Key facts

Study ID

NCT01561924

Run by

Novo Nordisk A/S

People needed

17

Starts

2005-11-01

Expected to finish

2006-05-01

Last updated by the study team

2016-11-23

Who can join

Age: 16 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Berkeley, California, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — Philadelphia, Pennsylvania, United States
• Novo Nordisk Investigational Site — Århus N, Denmark
• Novo Nordisk Investigational Site — Lyon, France
• Novo Nordisk Investigational Site — London, United Kingdom

Full record on ClinicalTrials.gov

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