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

October 17, 2014 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 1000005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
once a year in years 1-4

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 2, 2011

First Submitted That Met QC Criteria

March 10, 2011

First Posted (Estimate)

March 11, 2011

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 17, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7HAEM-3862
  • U1111-1116-1529 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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