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

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia B With Inhibitors; Haemophilia A With Inhibitors
• Interventions: Drug: activated recombinant human factor VII; Drug: Feiba VH

• Registration Number: NCT00710619
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

Inclusion Criteria

• Male subjects with congenital haemophilia A or B and inhibitors with spontaneous bleeds which require on-demand treatment
• Subjects prescribed NovoSeven® as the first line or recommended bypass agent
• History of on average at least 4 bleeds of any type over a 3 month period
• Subject or caregiver able and willing to complete daily journal for 3 months
• Informed consent obtained from all subjects or legal representative

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Feiba VH	-
A	activated recombinant human factor VII	-

Primary Outcome Measures

Name	Time	Method
Characterisation of dose and dosing intervals for each bleeding episode	after 3-6 months

Secondary Outcome Measures

Name	Time	Method
Effect of type of bleed on initial dose, dosing interval and total dose	after 3-6 months
Effect of initial dose and dosing interval on total dose, time to first perceived improvement, time to perceived bleed resolution	after 3-6 months
Effect of time to first dose on dosing interval and total dose	after 3-6 months
Effect of bleeds and drug administration time on planned daily activities	after 3-6 months
Relationship of dose and dosing intervals to reported SAEs	after 3-6 months

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Plainsboro, New Jersey, United States