Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

Novo Nordisk

Status and phase: Completed; Phase 2

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

NCT00108758

F7HAEM-1505

Details and patient eligibility

About

This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).

The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.

Enrollment: 23 patients

Sex: Male

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively

Exclusion criteria

• Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind