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

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

Secondary Outcome Measures:
  • Adverse events reported as potentially related to activated recombinant human factor VII [ Time Frame: after 25 exposure days ]

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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).

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 identifier: NCT01220141

Prov. de Buenos Aires, Argentina, B1636DSU
Vienna, Austria, A-1010
Brussels, Belgium, 1070
Paris La défense cedex, France, 92932
Mainz, Germany, 55127
Budapest, Hungary, 1025
Iran, Islamic Republic of
Teheran, Iran, Islamic Republic of
Dublin 2, Ireland
Rome, Italy, 00144
Warszawa, Poland, PL-02-274
Paco de Arcos, Portugal, 2780-730
Bratislava, Slovakia, 811 05
Malmö, Sweden, 202 15
United Kingdom
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01220141     History of Changes
Other Study ID Numbers: NN7025-3601
U1111-1116-2012 ( Other Identifier: WHO )
Study First Received: October 12, 2010
Last Updated: April 15, 2015

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 processed this record on May 22, 2017