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

Congenital Bleeding Disorder Clinical Trial

— DOSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710619
• Other study ID #: F7HAEM-1965
• Status: Completed
• Phase: N/A
• First received: July 3, 2008
• Last updated: November 16, 2016
• Start date: June 2008
• Est. completion date: July 2009

Study information

• Verified date: November 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A With Inhibitors
• Haemophilia B With Inhibitors
• Hemophilia A
• Hemophilia B
• Hemorrhage
• Hemostatic Disorders

Intervention

Drug:
• activated recombinant human factor VII
This is an observation of how patients/caregivers dose bypassing agents at home for haemophilia with inhibitors
• Feiba VH
This is an observation of how patients/caregivers dose bypassing agents at home for hemophilia with inhibitors

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Plainsboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterisation of dose and dosing intervals for each bleeding episode		after 3-6 months	No
Secondary	Effect of type of bleed on initial dose, dosing interval and total dose		after 3-6 months	No
Secondary	Effect of initial dose and dosing interval on total dose, time to first perceived improvement, time to perceived bleed resolution		after 3-6 months	No
Secondary	Effect of time to first dose on dosing interval and total dose		after 3-6 months	No
Secondary	Effect of bleeds and drug administration time on planned daily activities		after 3-6 months	No
Secondary	Relationship of dose and dosing intervals to reported SAEs		after 3-6 months	No

External Links

•   Clinical Trials at Novo Nordisk