Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B

April 15, 2015 updated by: Novo Nordisk A/S

Prospective Observational Study on NovoSeven® Room Temperature Stable (VII25) in Patients With Haemophilia A or B

This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

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

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

Male

Sampling Method

Probability Sample

Study Population

Male patients with haemophilia A or B with inhibitors treated with room temperature stable NovoSeven® (activated recombinant human factor VII).

Description

Inclusion Criteria:

  • Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX
  • Treated with room temperature stable 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
Administration of room temperature stable NovoSeven® (activated recombinant human factor VII) in dosages prescribed by the treating physician according to the product labelling text approved in his country.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory
Time Frame: after 25 exposure days
after 25 exposure days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events reported as potentially related to activated recombinant human factor VII
Time Frame: after 25 exposure days
after 25 exposure days

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

November 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 12, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7025-3601
  • U1111-1116-2012 (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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