Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America - Full Text View

Purpose

The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.

Condition	Intervention
Blood Coagulation Disorders Hemophilia A	Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Bleeding Disorders Hemophilia

Drug Information available for: Octocog alfa F8 protein, human Advate Adynovate

Genetic and Rare Diseases Information Center resources: Hemophilia Hemophilia A

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Total consumption of FVIII [ Time Frame: After 12 months and after 24 months ] [ Designated as safety issue: No ]
Number of bleedings [ Time Frame: After 12 months and after 24 months ] [ Designated as safety issue: No ]
Kind of bleedings [ Time Frame: After 12 months and after 24 months ] [ Designated as safety issue: No ]
Continuation of therapy [ Time Frame: After 12 months and after 24 months ] [ Designated as safety issue: No ]
Overall assessment by the physician [ Time Frame: After 12 months and after 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse event collection [ Time Frame: After 12 months and after 24 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

n.a.


Enrollment:	105
Study Start Date:	September 2009
Study Completion Date:	February 2014
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1	Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222) Patients under daily life treatment receiving Kogenate according to local drug information.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study population will consist of patients with a diagnosis of hemophilia A. Physicians should consult the full prescribing information for KOGENATE® FS before enrolling patients and familiarize themselves with the safety information in the product package label.

Criteria

Inclusion Criteria:

Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE® FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE® FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969319

Locations


Mexico

Many locations, Mexico
Venezuela

Many locations, Venezuela

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site


Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT00969319 History of Changes
Other Study ID Numbers:	14285 KG0802
Study First Received:	August 31, 2009
Last Updated:	January 16, 2015
Health Authority:	Mexico: Ethics Committee Venezuela: Ethics Committee

Keywords provided by Bayer:


Octocog alfa Hemophilia A

Additional relevant MeSH terms:


Hemophilia A Blood Coagulation Disorders Hemostatic Disorders Blood Coagulation Disorders, Inherited Hematologic Diseases Coagulation Protein Disorders	Hemorrhagic Disorders Genetic Diseases, Inborn Vascular Diseases Cardiovascular Diseases Factor VIII Coagulants

ClinicalTrials.gov processed this record on September 30, 2016