Observational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01312636
Recruitment Status : Completed
First Posted : March 11, 2011
Last Update Posted : October 20, 2014
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Japan. The aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in subjects with congenital FVII deficiency.

Condition or disease Intervention/treatment
Congenital Bleeding Disorder Congenital FVII Deficiency Drug: activated recombinant human factor VII

Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Official Title: A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Congenital FVII Deficiency - Registry for All Treated Patients
Study Start Date : March 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Group/Cohort Intervention/treatment
A Drug: activated recombinant human factor VII
Data will be collected at the baseline visit and approximately once a year until end of study.

Primary Outcome Measures :
  1. Presence and/or the appearance of inhibiting antibodies to factor VII and/or therapy-related thrombosis on using NovoSeven® under normal clinical practice conditions [ Time Frame: once a year in years 1-4 ]

Secondary Outcome Measures :
  1. To assess the treatment evaluation for bleeding episodes [ Time Frame: year 1, year 4 ]
  2. To assess the course and outcome of pregnancy in women treated with novoseven [ Time Frame: until 1 month after giving birth ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All subjects with a FVII deficiency to whom activated recombinant human factor VII (NovoSeven®) is administered

Inclusion Criteria:

  • Congenital FVII deficiency
  • Never been treated with NovoSeven® before
  • Patients already in treatment with NovoSeven®

Exclusion Criteria:

  • History of hypersensitivity to any of the components in NovoSeven®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01312636

Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01312636     History of Changes
Other Study ID Numbers: F7HAEM-3862
U1111-1116-1529 ( Other Identifier: WHO )
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: October 20, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders