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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.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00710619
First received: July 3, 2008
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Characterisation of dose and dosing intervals for each bleeding episode [ Time Frame: after 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of type of bleed on initial dose, dosing interval and total dose [ Time Frame: after 3-6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Effect of time to first dose on dosing interval and total dose [ Time Frame: after 3-6 months ] [ Designated as safety issue: No ]
  • Effect of bleeds and drug administration time on planned daily activities [ Time Frame: after 3-6 months ] [ Designated as safety issue: No ]
  • Relationship of dose and dosing intervals to reported SAEs [ Time Frame: after 3-6 months ] [ Designated as safety issue: No ]

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

  Eligibility

Genders 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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710619

Locations
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: David L. Cooper, MD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00710619     History of Changes
Other Study ID Numbers: F7HAEM-1965
Study First Received: July 3, 2008
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemophilia B
Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Hematologic Diseases
 Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013