Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX (DOSE)
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ClinicalTrials.gov Identifier: NCT00710619 |
Recruitment Status
:
Completed
First Posted
: July 4, 2008
Last Update Posted
: November 17, 2016
|
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Condition or disease | Intervention/treatment |
---|---|
Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors | Drug: activated recombinant human factor VII Drug: Feiba VH |
Study Type : | Observational |
Actual Enrollment : | 52 participants |
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 |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | July 2009 |

Group/Cohort | Intervention/treatment |
---|---|
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
|
- Characterisation of dose and dosing intervals for each bleeding episode [ Time Frame: after 3-6 months ]
- 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 ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710619
United States, New Jersey | |
Novo Nordisk Investigational Site | |
Plainsboro, New Jersey, United States, 08536 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT00710619 History of Changes |
Other Study ID Numbers: |
F7HAEM-1965 |
First Posted: | July 4, 2008 Key Record Dates |
Last Update Posted: | November 17, 2016 |
Last Verified: | November 2016 |
Additional relevant MeSH terms:
Hemophilia A Hemophilia B Hemorrhage 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 |