check_circleStudy Completed

Blood Coagulation Disorders, Hemophilia A

Bayer Identifier:

14285

ClinicalTrials.gov Identifier:

NCT00969319

EudraCT Number:

Not Available

EU CT Number:

Not Available
Effekt-2 - Efficacy and Safety of long-term treatment with KOGENATE® FS in Latin America

Trial 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.

Key Participants Requirements

Sex

Male

Age

0 - N/A
  • - 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.

Trial summary

Enrollment Goal
105
Trial Dates
September 2009 - February 2014
Phase
N/A
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Mexico
Completed
Many locations, Venezuela

Primary Outcome

  • Total consumption of FVIII
    date_rangeTime Frame:
    After 12 months and after 24 months
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    Safety Issue:
    No
  • Number of bleedings
    date_rangeTime Frame:
    After 12 months and after 24 months
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    Safety Issue:
    No
  • Kind of bleedings
    date_rangeTime Frame:
    After 12 months and after 24 months
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    Safety Issue:
    No
  • Continuation of therapy
    date_rangeTime Frame:
    After 12 months and after 24 months
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    Safety Issue:
    No
  • Overall assessment by the physician
    date_rangeTime Frame:
    After 12 months and after 24 months
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    Safety Issue:
    No

Secondary Outcome

  • Adverse event collection
    date_rangeTime Frame:
    After 12 months and after 24 months
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    Safety Issue:
    Yes

Trial design

Effekt-2 - Efficacy and Safety of long-term treatment with KOGENATE® FS in Latin America
Trial Type
Observational
Intervention Type
Biological/Vaccine
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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