PROPACT: Retrospective Prophylaxis Patient Case Collection

Novo Nordisk

Status: Completed

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

Treatments: Drug: eptacog alfa (activated)

Study type: Observational

Funder types: Industry

Identifiers

NCT00882778

F7HAEM-3695

Details and patient eligibility

About

This study is conducted in Europe and North and South America. The primary aim of this observational study is to evaluate the frequency and pattern of bleeding episodes in haemophilia patients receiving preventative treatment with activated recombinant human factor VII. The secondary aim is to evaluate which patients are selected for this treatment, the dose and dose intervals used, and the safety of activated recombinant human factor VII when used as prevention. The study also aims to increase understanding of the unmet medical need and clinical relevance of preventative treatment in haemophilia patients.

Enrollment: 86 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Haemophilia A or B with inhibitors
• Prescribed use of activated recombinant human factor VII for any type of prophylaxis with a duration of at least 30 days

Exclusion criteria

• Prophylaxis prescribed post-surgery
• One or more coagulation disorders in addition to haemophilia

Trial design

86 participants in 1 patient group

activated recombinant human factor VII

Description:

Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.

Treatment:

Drug: eptacog alfa (activated)