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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:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00710619
First received: July 3, 2008
Last updated: November 16, 2016
Last verified: November 2016
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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:
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
|
Eligibility| 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
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00710619
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710619
Locations
| United States, New Jersey | |
| Novo Nordisk Investigational Site | |
| Plainsboro, New Jersey, United States, 08536 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
More Information
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 |
| Study First Received: | July 3, 2008 |
| Last Updated: | November 16, 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 |
ClinicalTrials.gov processed this record on August 18, 2017