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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01312636
First received: March 2, 2011
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

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 Intervention
Congenital Bleeding Disorder
Congenital FVII Deficiency
Drug: activated recombinant human factor VII

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: March 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: activated recombinant human factor VII
Data will be collected at the baseline visit and approximately once a year until end of study.

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

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®
  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: NCT01312636

Locations
Japan
Tokyo, Japan, 1000005
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: NCT01312636     History of Changes
Other Study ID Numbers: F7HAEM-3862, U1111-1116-1529
Study First Received: March 2, 2011
Last Updated: October 17, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on October 19, 2014