Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia - Full Text View

Purpose

This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).

The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.

Condition	Intervention	Phase
Hemophilia A Hemophilia B	Drug: Activated Recombinant FVII (NovoSeven®)	Phase II

Genetics Home Reference related topics:

hemophilia L1 syndrome

MedlinePlus related topics:

Hemophilia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Efficacy Study

Official Title:	Evaluating the Efficacy of Activated Recombinant Factor VII (NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Reduction of bleeds during 3 months treatment period as compared to 3 months observation period

Secondary Outcome Measures:

Efficacy variables

Estimated Enrollment:	60
Study Start Date:	March 2004

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively

Exclusion Criteria

Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108758

Locations


United States, California

	Berkeley, California, United States, 94704

United States, Iowa

	Iowa City, Iowa, United States, 52242

United States, Pennsylvania

	Philadelphia, Pennsylvania, United States, 19104

Argentina

	Buenos Aires, Argentina

Brazil

	Campinas, Brazil

	Rio de Janeiro, Brazil

Bulgaria

	Sofia, Bulgaria

Philippines

	Manila, Philippines

Poland

	Warszawa, Poland

Romania

	Bucharest, Romania

	Timisoara, Romania

Russian Federation

	Moscow, Russian Federation

South Africa

	Parktown, South Africa

Spain

	Santander, Spain

	Madrid, Spain

	Sevilla, Spain

Turkey

	Izmir, Turkey

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Ute Friedrich, PhD	Novo Nordisk A/S

More Information

Study ID Numbers:	F7HAEM-1505
First Received:	April 18, 2005
Last Updated:	September 18, 2006
ClinicalTrials.gov Identifier:	NCT00108758
Health Authority:	United States: Food and Drug Administration; Spain: Spanish Agency of Medicines; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency; Bulgaria: Ministry of Health; Philippines: Bureau of Food and Drugs; Poland: Ministry of Health; Romania: State Institute for Drug Control; Russia: Pharmacological Committee, Ministry of Health; South Africa: Medicines Control Council; Turkey: Ministry of Health

Study placed in the following topic categories:

Hemophilia B

Hemorrhagic Disorders

Genetic Diseases, Inborn

Hematologic Diseases

Blood Coagulation Disorders

Hemophilia A

Genetic Diseases, X-Linked

Neoplasm Metastasis

Hemostatic Disorders

Hemorrhage

Additional relevant MeSH terms:

Blood Coagulation Disorders, Inherited

Coagulation Protein Disorders

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00108758