check_circleStudy Completed

Hemophilia A

Bayer Identifier:

14344

ClinicalTrials.gov Identifier:

NCT00932555

EudraCT Number:

Not Available

EU CT Number:

Not Available
EffeKt Taiwan- Efficacy and Safety of long-term treatment with KOGENATE® FS in Taiwan

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
82
Trial Dates
April 2009 - December 2011
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, Taiwan

Primary Outcome

  • Efficacy and Safety of Kogenate FS
    date_rangeTime Frame:
    After 12 months and after 24 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

EffeKt Taiwan- Efficacy and Safety of long-term treatment with KOGENATE® FS in Taiwan
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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