Observational Study on the Efficacy and Safety of NovoSeven® During "Real-Life" Usage in Germany - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00697320

Purpose

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	Intervention
Haemophilia	Drug: activated recombinant human factor VII

Genetics Home Reference related topics: hemophilia

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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® ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time proportion of acute bleeding treatments resulting in effective pain relief [ Time Frame: within 9 hours after initiation of treatment with NovoSeven® ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: activated recombinant human factor VII A NON INTERVENTIONAL OBSERVATIONAL STUDY: Doses and frequency of injections to be prescribed by the physician as a result of the normal clinical evaluation

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697320

Contacts

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Locations

Germany
	Recruiting
Mainz, Germany, 55127

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Peter Lampen, PhD

Novo Nordisk Pharma GmbH

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	F7HAEM-1921
Study First Received:	June 11, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00697320
Health Authority:	Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Thrombocytopathy
Thrombasthenia of Glanzmann and Naegeli
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases

Blood Platelet Disorders
Blood Coagulation Disorders
Hemophilia A
Thrombasthenia
Hemostatic Disorders

Additional relevant MeSH terms:

Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders

ClinicalTrials.gov processed this record on January 16, 2009