High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

Novo Nordisk

Status and phase

Completed

Phase 4

Conditions

Haemophilia B With Inhibitors

Haemophilia A With Inhibitors

Congenital Bleeding Disorder

Treatments

Drug: activated recombinant human factor VII

Study type

Interventional

Funder types

Industry

Identifiers

NCT00571584

F7HEAM-1510

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.

Enrollment

24 patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed of congenital haemophilia A or B with inhibitors to factor VIII or IX, respectively
A history of 3 or more joint bleeds during the last 12 months

Exclusion criteria

Joint bleeding within 7 days prior to trial start
Treatment for bleeds within the last 5 days prior to trial start
Clinically relevant coagulation disorders other than congenital haemophilia A or B