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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01312636
First received: March 2, 2011
Last updated: August 27, 2014
Last verified: August 2014

March 2, 2011
August 27, 2014
March 2011
September 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01312636 on ClinicalTrials.gov Archive Site
  • To assess the treatment evaluation for bleeding episodes [ Time Frame: year 1, year 4 ] [ Designated as safety issue: No ]
  • To assess the course and outcome of pregnancy in women treated with novoseven [ Time Frame: until 1 month after giving birth ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII Deficiency
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

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.

Not Provided
Observational
Observational Model: Cohort
Not Provided
Not Provided
Probability Sample

All subjects with a FVII deficiency to whom activated recombinant human factor VII (NovoSeven®) is administered

  • Congenital Bleeding Disorder
  • Congenital FVII Deficiency
Drug: activated recombinant human factor VII
Data will be collected at the baseline visit and approximately once a year until end of study.
A
Intervention: Drug: activated recombinant human factor VII
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
September 2014
September 2014   (final data collection date for primary outcome measure)

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®
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01312636
F7HAEM-3862, U1111-1116-1529
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP