PROPACT: Retrospective Prophylaxis Patient Case Collection - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00882778

Purpose

This study is conducted in Europe and North and South America. The priamry aim of this observational study is to evaluate the frequency and pattern of bleeding episodes in haemophilia patients receiving preventative treatment with activated recombinant human factor VII (NovoSeven®). The secondary aim is to evaluate which patients are selected for this treatment, the dose and dose intervals used, and the safety of NovoSeven®) when used as prevention. The study also aims to increase understanding of the unmet medical need and clinical relevance of preventative treatment in haemophilia patients.

Condition	Intervention
Haemophilia	Drug: activated recombinant human factor VII

Genetics Home Reference related topics: hemophilia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Retrospective
Official Title:	Prophylactic Treatment With Recombinant Factor VIIa (rFVIIa, NovoSeven®) in Haemophilia Patients With Inhibitors

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Bleeding and treatment history [ Time Frame: during the 6 months prior to start of prophylaxis, during prophylaxis and during the 6 months after prophylaxis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prophylactic regimen, including physician assessment of prophylaxis outcome, quality of life and joint status if available [ Time Frame: at the end of prophylaxis period (min 4 weeks) ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	April 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: activated recombinant human factor VII Retrospective data collection of the use of recombinant factor VIIa as prophylaxis in haemophilia patients with inhibitors

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Haemophilia patients in specialist hospital clinic or private clinic settings

Criteria

Inclusion Criteria:

Haemophilia A or B with inhibitors
Prescribed use of NovoSeven® for any type of prophylaxis with a duration of at least 30 days

Exclusion Criteria:

Prophylaxis prescribed post-surgery
One or more coagulation disorders in addition to haemophilia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882778

Contacts

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Locations

United States, New Jersey
Novo Nordisk Clinical Trial Call Center	Recruiting
Princeton, New Jersey, United States, 08540
Argentina
	Recruiting
Prov. de Buenos Aires, Argentina, B1636DSU
Canada, Ontario
	Recruiting
Mississauga, Ontario, Canada, L4W 4XI
Croatia
	Recruiting
Zagreb, Croatia, 10 000
Czech Republic
	Recruiting
Prague, Czech Republic, 16000
Germany
	Recruiting
Mainz, Germany, 55127
Ireland
	Recruiting
Dublin 2, Ireland
Italy
	Recruiting
Rome, Italy, 00144
Norway
	Recruiting
Rud, Norway, 1309
Slovakia
	Recruiting
Bratislava, Slovakia, 811 05
Spain
	Recruiting
Madrid, Spain, 28033
Sweden
	Recruiting
Malmö, Sweden, SE-202 15
Switzerland, Oerlikon
	Recruiting
Zurich, Oerlikon, Switzerland, CH-8050
United Kingdom, West Sussex
	Recruiting
Crawley, West Sussex, United Kingdom, RH11 9RT

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Stefan Bosbach, Ph.D

Novo Nordisk Health Care AG

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	F7HAEM-3695
Study First Received:	April 14, 2009
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00882778 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Public Health Agency of Canada; Croatia: Ministry of Health and Social Care; Czech Republic: State Institute for Drug Control; Germany: BfArM and Paul-Ehrlich Institute (PEI); Italy: AIFA; Slovakia: State Institute for Drug Control; Spain: AGEMED; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

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:

Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn
Coagulation Protein Disorders

Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A

ClinicalTrials.gov processed this record on May 06, 2009