Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors Under Normal Clinical Practice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01579955
First received: April 11, 2012
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) under normal clinical practice conditions.


Condition Intervention
Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Drug: eptacog alfa (activated)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors Under Normal Clinical Practice

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective [ Time Frame: Year 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events (AEs), including serious adverse events (SAEs) [ Time Frame: Baseline, every 1 year, Year 10 ] [ Designated as safety issue: No ]

Enrollment: 321
Study Start Date: March 1999
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
eptacog alpha users Drug: eptacog alfa (activated)
Prescription of eptacog alpha at the discretion of the physician

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with haemophilia A and B with inhibitors who received NovoSeven® (eptacog alpha)

Criteria

Inclusion Criteria:

  • Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment

Exclusion Criteria:

  • Patients who was not deemed to be appropriate to the treatment of eptacog alpha (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: NCT01579955

Locations
Japan
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Hiroshi Tsuchiya Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01579955     History of Changes
Other Study ID Numbers: F7-1947
Study First Received: April 11, 2012
Last Updated: August 8, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemophilia A
Hemophilia B
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases
Factor VIII
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014