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

Hemophilia A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969319
• Other study ID #: 14285
• Secondary ID: KG0802
• Status: Completed
• Phase: N/A
• First received: August 31, 2009
• Last updated: January 16, 2015
• Start date: September 2009
• Est. completion date: February 2014

Study information

• Verified date: January 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics CommitteeVenezuela: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: February 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemophilia A
• Hemostatic Disorders

Intervention

Biological:
• Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Patients under daily life treatment receiving Kogenate according to local drug information.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Mexico,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total consumption of FVIII		After 12 months and after 24 months	No
Primary	Number of bleedings		After 12 months and after 24 months	No
Primary	Kind of bleedings		After 12 months and after 24 months	No
Primary	Continuation of therapy		After 12 months and after 24 months	No
Primary	Overall assessment by the physician		After 12 months and after 24 months	No
Secondary	Adverse event collection		After 12 months and after 24 months	Yes

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