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: August 30, 2012
Last verified: August 2012
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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:
Genetics Home Reference related topics:
hemophilia
Drug Information available for:
FEIBA
Genetic and Rare Diseases Information Center resources:
Hemophilia
Hemophilia A, Congenital
Hemophilia B
U.S. FDA Resources
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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 Clinical Trial Call Center | |
| Princeton, New Jersey, United States, 08540 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | David L. Cooper, MD | Novo Nordisk A/S |
More Information
Additional Information:
No publications provided by Novo Nordisk A/S
Additional 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: | August 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hemophilia B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders |
Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on March 03, 2015