Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B
This study is ongoing, but not recruiting participants.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01220141
First received: October 12, 2010
Last updated: May 21, 2013
Last verified: May 2013
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Purpose
This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).
| Condition | Intervention |
|---|---|
|
Congenital Bleeding Disorder Haemophilia A Haemophilia B |
Drug: activated recombinant human factor VII |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective Observational Study on NovoSeven® Room Temperature Stable (VII25) in Patients With Haemophilia A or B |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory [ Time Frame: after 25 exposure days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events reported as potentially related to activated recombinant human factor VII [ Time Frame: after 25 exposure days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| A |
Drug: activated recombinant human factor VII
Administration of room temperature stable NovoSeven® (activated recombinant human factor VII) in dosages prescribed by the treating physician according to the product labelling text approved in his country.
|
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Male patients with haemophilia A or B with inhibitors treated with room temperature stable NovoSeven® (activated recombinant human factor VII).
Criteria
Inclusion Criteria:
- Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX
- Treated with room temperature stable NovoSeven®
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220141
Locations
| Argentina | |
| Prov. de Buenos Aires, Argentina, B1636DSU | |
| Austria | |
| Vienna, Austria, A-1010 | |
| Belgium | |
| Brussels, Belgium, 1070 | |
| France | |
| Paris La défense cedex, France, 92932 | |
| Germany | |
| Mainz, Germany, 55127 | |
| Hungary | |
| Budapest, Hungary, 1025 | |
| Iran, Islamic Republic of | |
| Teheran, Iran, Islamic Republic of | |
| Ireland | |
| Dublin 2, Ireland | |
| Italy | |
| Rome, Italy, 00144 | |
| Poland | |
| Warszawa, Poland, PL-02-274 | |
| Portugal | |
| Paco de Arcos, Portugal, 2780-730 | |
| Slovakia | |
| Bratislava, Slovakia, 811 05 | |
| Sweden | |
| Malmö, Sweden, SE-202 15 | |
| United Kingdom | |
| Crawley, United Kingdom, RH11 9RT | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Janne Ulbak | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01220141 History of Changes |
| Other Study ID Numbers: | NN7025-3601, U1111-1116-2012 |
| Study First Received: | October 12, 2010 |
| Last Updated: | May 21, 2013 |
| Health Authority: | Austria: Not required for observational study in Austria Belgium: Not required for observational study in Belgium France: Not required for observational study Germany: Not required for observational study Ireland: Not required for observational study Italy: Not required for observational study Poland: Not required for observational study Sweden: Not required for observational study Turkey: Not required for observational study United Kingdom: Not required for observational study Hungary: Not required for observational study Portugal: Not required for observational study Iran: Ministry of Health and Medical Education |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Hemophilia B Hemophilia A Hemorrhage Hematologic Diseases Vascular Diseases Cardiovascular Diseases Blood Coagulation Disorders, Inherited |
Coagulation Protein Disorders Genetic Diseases, Inborn Genetic Diseases, X-Linked Pathologic Processes Factor VIII Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013