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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | This is an observation of how patients/caregivers dose bypassing agents at home for haemophilia with inhibitors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterisation of dose and dosing intervals for each bleeding episode | after 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of type of bleed on initial dose, dosing interval and total dose | after 3-6 months | |
| Effect of initial dose and dosing interval on total dose, time to first perceived improvement, time to perceived bleed resolution | after 3-6 months |
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Inclusion Criteria:
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Male subjects with congenital haemophilia A or B with inhibitors with spontaneous bleeds requiring on-demand treatment
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Plainsboro | New Jersey | 08536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23551918 | Derived | Gruppo RA, Kessler CM, Neufeld EJ, Cooper DL. Assessment of individual dose utilization vs. physician prescribing recommendations for recombinant activated factor VII (rFVIIa) in paediatric and adult patients with congenital haemophilia and alloantibody inhibitors (CHwI): the Dosing Observational Study in Hemophilia (DOSE). Haemophilia. 2013 Jul;19(4):524-32. doi: 10.1111/hae.12113. Epub 2013 Apr 1. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Feiba VH | Drug | This is an observation of how patients/caregivers dose bypassing agents at home for hemophilia with inhibitors |
|
| Effect of time to first dose on dosing interval and total dose | after 3-6 months |
| Effect of bleeds and drug administration time on planned daily activities | after 3-6 months |
| Relationship of dose and dosing intervals to reported SAEs | after 3-6 months |
| ID | Term |
|---|---|
| C065655 | anti-inhibitor coagulant complex |
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