High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

This study has been completed.

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00571584

Purpose

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.

Condition	Intervention	Phase
Haemophilia	Drug: activated recombinant human factor VII	Phase IV

Genetics Home Reference related topics: hemophilia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	High Dose Versus Standard Multiple Doses of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Global treatment response of the patient by an algorithm based pain and joint mobility assessments

Secondary Outcome Measures:

Pain assessment
Mobility assessment
Circumference of joint
Adverse events

Estimated Enrollment:	24
Study Start Date:	November 2002

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed of congenital haemophilia A or B with inhibitors to factor VIII or IX, respectively
A history of 3 or more joint bleeds during the last 12 months

Exclusion Criteria:

Joint bleeding within 7 days prior to trial start
Treatment for bleeds within the last 5 days prior to trial start
Clinically relevant coagulation disorders other than congenital haemophilia A or B

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571584

Locations

France

Paris, France, 75015
Hungary

Budapest, Hungary, 1135
Israel

Tel-Hashomer, Israel, 52621
Spain

Madrid, Spain, 28046
Turkey

Capa-ISTANBUL, Turkey, 35100
United Kingdom

Birmingham, United Kingdom, B15 2TH

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Peter Schelde, MSc

Novo Nordisk

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:	F7HEAM-1510
Study First Received:	December 11, 2007
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00571584
Health Authority:	Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory; Hungary: National Institute of Pharmacy; Israel: Israeli Health Ministry Pharmaceutical Administration; Turkey: Ministry of Health Drug and Pharmaceutical Department

Study placed in the following topic categories:

Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases

Blood Coagulation Disorders
Hemophilia A
Hemostatic Disorders

Additional relevant MeSH terms:

Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders

ClinicalTrials.gov processed this record on January 13, 2009