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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment
Congenital Bleeding Disorder; Congenital FVII Deficiency; Glanzmann's Disease; Acquired Bleeding Disorder; Acquired Haemophilia	Drug: eptacog alfa (activated)

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	64 participants
Time Perspective:	Prospective
Official 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
Study Start Date :	June 2008
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	December 2010

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
A	Drug: eptacog alfa (activated); 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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Time proportion of acute bleeding treatments resulting in effective pain relief [ Time Frame: within 9 hours after initiation of treatment with NovoSeven® ]
2. 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) ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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®.

Criteria

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Novo Nordisk Investigational Site
Mainz, Germany, 55127

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Clinical Trials at Novo Nordisk 

Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00697320 History of Changes
Other Study ID Numbers:	F7HAEM-1921
First Posted:	June 13, 2008
Last Update Posted:	December 7, 2016
Last Verified:	December 2016

Additional relevant MeSH terms:

Disease; Hemorrhage; Hemophilia A; Blood Coagulation Disorders; Hemostatic Disorders; Hemorrhagic Disorders; Thrombasthenia; Pathologic Processes	Blood Coagulation Disorders, Inherited; Hematologic Diseases; Coagulation Protein Disorders; Genetic Diseases, Inborn; Vascular Diseases; Cardiovascular Diseases; Blood Platelet Disorders