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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: July 3, 2008
Last updated: November 16, 2016
Last verified: November 2016
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.

Condition Intervention
Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Drug: activated recombinant human factor VII
Drug: Feiba VH

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Characterisation of dose and dosing intervals for each bleeding episode [ Time Frame: after 3-6 months ]

Secondary Outcome Measures:
  • Effect of type of bleed on initial dose, dosing interval and total dose [ Time Frame: after 3-6 months ]
  • Effect of initial dose and dosing interval on total dose, time to first perceived improvement, time to perceived bleed resolution [ Time Frame: after 3-6 months ]
  • Effect of time to first dose on dosing interval and total dose [ Time Frame: after 3-6 months ]
  • Effect of bleeds and drug administration time on planned daily activities [ Time Frame: after 3-6 months ]
  • Relationship of dose and dosing intervals to reported SAEs [ Time Frame: after 3-6 months ]

Enrollment: 52
Study Start Date: June 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A 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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male subjects with congenital haemophilia A or B with inhibitors with spontaneous bleeds requiring on-demand treatment

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00710619

United States, New Jersey
Novo Nordisk Investigational Site
Plainsboro, New Jersey, United States, 08536
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S Identifier: NCT00710619     History of Changes
Other Study ID Numbers: F7HAEM-1965
Study First Received: July 3, 2008
Last Updated: November 16, 2016

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases processed this record on May 25, 2017