NCT00710619

Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX

Dosing Observational Study in Hemophilia Subjects With Inhibitors: A Phase IV Diary Study in Subjects Prescribed NovoSeven® as First Line on Demand Therapy for Acute Bleeding Episodes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is conducted in the United States of America (USA). The aim of this study is to investigate the at-home-administration of bypassing agents for treatment of bleeding episodes in patients with congenital haemophilia with inhibitors to factors VIII and IX. We are further investigating how bleeding episodes affect the quality of life of the patient and their family or caregivers.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A With Inhibitors
• Haemophilia B With Inhibitors

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII	This is an observation of how patients/caregivers dose bypassing agents at home for haemophilia with inhibitors
DRUG	Feiba VH	This is an observation of how patients/caregivers dose bypassing agents at home for hemophilia with inhibitors

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-07-04
• Last updated: 2016-11-17

Locations

1 site across 1 country: United States