Observational Registry of NovoSeven® Used as on-Demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00703911

Purpose

This study is conducted in Europe.

The primary objective of this registry is to observe the use of single dose and multi-dose use of NovoSeven® and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.

Condition	Intervention
Haemophilia A Haemophilia B	Drug: activated recombinant human factor VII

Genetics Home Reference related topics: hemophilia L1 syndrome

MedlinePlus related topics: Hemophilia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Efficacy and Safety of NovoSeven® (Activated Recombinant Human Factor VII) Used as on-Demand Treatment of Mild to Moderate Bleeds in Patients With Haemophilia A and B With Inhibitors

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Proportion of bleed treatments resulting in effective haemostasis [ Time Frame: 9 hours after first injection, for each bleeding episode ] [ Designated as safety issue: No ]
Proportion of bleed treatments resulting in effective pain relief [ Time Frame: 9 hours after first injection, for each bleeding episode ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Treatment satisfaction and convenience [ Time Frame: after each bleeding episode ] [ Designated as safety issue: No ]
Haemostasis/pain relief [ Time Frame: 1 hour, 3 hours and 6 hours after start of each bleed ] [ Designated as safety issue: No ]
Adverse events reported as potentially related to NovoSeven [ Time Frame: up to 28 days after discontinuation from the study ] [ Designated as safety issue: Yes ]
Total number of injections/doses [ Time Frame: 48 hours after start of each bleed ] [ Designated as safety issue: No ]
Quality of Life questionnaire (voluntary) [ Time Frame: at study discontinuation ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	March 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: activated recombinant human factor VII Treatment of patients experiencing bleeds at the discretion of the physician/caregiver.

Eligibility

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

Study Population

Haemophilia A and B patients with inhibitors, using NovoSeven® as on-demand treatment

Criteria

Inclusion Criteria:

Diagnosed with haemophilia A or B with inhibitors
Experience mild to moderate spontaneous bleeds which require on-demand treatment and who are currently prescribed NovoSeven
Be able and willing to provide informed consent (or proxy consent by caregiver, if applicable), as required by local research ethics committee, governmental or regulatory authorities.
Be willing to provide information on at least one alternate contact person in the event that the patient be somehow lost-to-follow-up over the course of registry participation (not applicable if patient is withdrawn).

Exclusion Criteria:

Known hypersensitivity to the active substance or the excipients in the formulation of NovoSeven, or to mouse, hamster or bovine protein

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703911

Contacts

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Show 20 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Paulo André Palhares de Miranda

Novo Nordisk Health Care AG

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-3507
Study First Received:	June 19, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00703911
Health Authority:	Poland: Office for Reg Med Prod, Devices, Biocidal Prod, Central Reg CT; Netherlands: The Central Committee on Research Involving Human Subjects (CCM; Spain: Spanish Agency of Medicines

Keywords provided by Novo Nordisk:

Haemophilia A or B with inhibitors

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
Hemostatic Disorders

Additional relevant MeSH terms:

Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders

ClinicalTrials.gov processed this record on January 16, 2009