EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00874926

Enrollment

405

Registered

2009-04-03

Start date

2008-06-30

Completion date

2013-04-30

Last updated

2014-01-29

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, Haemophilia A

Brief summary

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

Interventions

BIOLOGICALRecombinant Factor VIII (Kogenate FS, BAY14-2222)

Haemophilia A patients

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/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.

Exclusion criteria

Design outcomes

Primary

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

Countries

Bahrain, Bosnia and Herzegovina, Croatia, Germany, Israel, Kazakhstan, Kuwait, Libya, Morocco, Oman, Qatar, Romania, Russia, Saudi Arabia, Slovenia, Tunisia, United Arab Emirates

Outcome results

None listed

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