Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany

This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.

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Key information

Conditions

Congenital Bleeding Disorder Acquired Bleeding Disorder Acquired Haemophilia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Congenital FVII Deficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Glanzmann's Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Thrombasthenia

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Mainz, 55127, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written informed consent obtained from patient or patient's legally acceptable representative in which he agrees that the patient's pseudonymised personal data will be transferred for use in a scientific evaluation and publication

Exclusion criteria

Due to the non-interventional observational character of the study, there are no exclusion criteria.

Treatment and study plan

eptacog alfa (activated)

Drug

A NON INTERVENTIONAL OBSERVATIONAL STUDY:

Doses and frequency of injections to be prescribed by the physician as a result of the normal clinical evaluation

Other names: NovoSeven®, F7, activated recombinant human factor VII

Primary outcomes

Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved

Time frame: within 9 hours after initiation of treatment with NovoSeven® or of invasive procedures for which haemostasis will be maintained during the time period of haemostatic coverage with NovoSeven®

Secondary outcomes

Time proportion of acute bleeding treatments resulting in effective pain relief

Time frame: within 9 hours after initiation of treatment with NovoSeven®
Proportion of patients experiencing one or more re-bleeds

Time frame: within 24 hours after begin of an acute bleeding episode that was successfully treated with NovoSeven® (stop or significant reduction of bleeding)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy of NovoSeven® (Activated Recombinant Human Factor VII): Non-interventional Study in Patients With Congenital Haemophilia With Inhibitors, Acquired Haemophilia, Factor FVII Deficiency, and Glanzmann's Thrombasthenia

Acronym: WIRK

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Jun 13, 2008
Registry last updated: Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed