Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01220141
First received: October 12, 2010
Last updated: April 15, 2015
Last verified: April 2015
  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 ]

Enrollment: 51
Study Start Date: November 2010
Study Completion Date: March 2015
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

Ages Eligible for Study:   Child, Adult, Senior
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
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: 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:
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: April 15, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
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
Hungary: Not required for observational study
Iran: Ministry of Health and Medical Education
Ireland: Not required for observational study
Italy: Not required for observational study
Poland: Not required for observational study
Portugal: Not required for observational study
Slovakia: State Institute for Drug Control
Sweden: Not required for observational study
United Kingdom: Not required for observational study

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants

ClinicalTrials.gov processed this record on August 28, 2016