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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01220141
First received: October 12, 2010
Last updated: January 22, 2014
Last verified: January 2014
  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 A/S:

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: March 2015
Estimated Primary Completion Date: March 2015 (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, 202 15
United Kingdom
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01220141     History of Changes
Other Study ID Numbers: NN7025-3601, U1111-1116-2012
Study First Received: October 12, 2010
Last Updated: January 22, 2014
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 April 17, 2014