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

NCT ID: NCT01220141

Last Updated: 2015-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Bleeding Disorder Haemophilia A Haemophilia B

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

activated recombinant human factor VII

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX
* Treated with room temperature stable NovoSeven®
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Prov. de Buenos Aires, , Argentina

Site Status

Vienna, , Austria

Site Status

Brussels, , Belgium

Site Status

Paris La Défense Cedex, , France

Site Status

Mainz, , Germany

Site Status

Budapest, , Hungary

Site Status

Tehran, , Iran

Site Status

Dublin, , Ireland

Site Status

Rome, , Italy

Site Status

Warsaw, , Poland

Site Status

Paço de Arcos, , Portugal

Site Status

Bratislava, , Slovakia

Site Status

Malmo, , Sweden

Site Status

Crawley, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Argentina Austria Belgium France Germany Hungary Iran Ireland Italy Poland Portugal Slovakia Sweden United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1116-2012

Identifier Type: OTHER

Identifier Source: secondary_id

NN7025-3601

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.