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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
ClinicalTrials.gov Identifier:
NCT01312636
First received: March 2, 2011
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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: 15
Study Start Date: March 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312636

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Hiroshi Tsuchiya Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01312636     History of Changes
Other Study ID Numbers: F7HAEM-3862, U1111-1116-1529
Study First Received: March 2, 2011
Last Updated: April 15, 2013
Health Authority: Japan: Pharmaceuticals and medical devices agency (PMDA)

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

ClinicalTrials.gov processed this record on May 23, 2013