EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00932555

Enrollment

Registered

2009-07-03

Start date

2009-04-30

Completion date

2011-12-31

Last updated

2012-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

Octocog alfa, Hemophilia A

Brief 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.

Interventions

BIOLOGICALRecombinant Factor VIII (Kogenate FS, BAY14-2222)

Patients under daily life treatment receiving Kogenate according to local drug information.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Efficacy and Safety of Kogenate FS	After 12 months and after 24 months

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026