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Clinical Trial Name -EFFEKT - Efficacy and Safety of Long-Term Treatment With KOGENATE Bayer/FS
| Original Study ID : 13405 |
| Secondary ID : KG 0702 |
| NCT ID : NCT00874926 |
| Brief Title : EFFEKT - Efficacy and Safety of Long-Term Treatment With KOGENATE Bayer/FS |
| Official Title : Efficacy and Safety of Long-Term Treatment With KOGENATE Bayer/FS |
| 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. |
| Source : Bayer |
| Overall Status : Recruiting |
| Start Date : June 2008 |
| End Date : June 2011 |
| Completion Date : June 2011 |
| Official Title : Phase 4 |
| Phase : Observational |
| Study Design : Cohort, Prospective |
| Enrollment : 150 |
| Verification Date : May 2009 |
| First Received Date : April 2, 2009 |
| Trial Eligibility |
| Criteria : 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: Exclusion criteria must be read in conjunction with the local product information. |
| Gender : Male |
| Minimum Age : N/A |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Status : Recruiting |
| City : Many Locations |
| Country : Bahrain |
| Status : Recruiting |
| City : Many Locations |
| Country : Bosnia and Herzegovina |
| Status : Not yet recruiting |
| City : Many Locations |
| Country : Croatia |
| Status : Not yet recruiting |
| City : Many Locations |
| Country : Germany |
| Status : Not yet recruiting |
| City : Many Locations |
| Country : Israel |
| Status : Not yet recruiting |
| City : Many Locations |
| Country : Kazakhstan |
| Status : Recruiting |
| City : Many Locations |
| Country : Kuwait |
| Status : Not yet recruiting |
| City : Many Locations |
| Country : Morocco |
| Status : Recruiting |
| City : Many Locations |
| Country : Oman |
| Status : Recruiting |
| City : Many Locations |
| Country : Qatar |
| Status : Not yet recruiting |
| City : Many Locations |
| Country : Romania |
| Status : Recruiting |
| City : Many Locations |
| Country : Russian Federation |
| Status : Recruiting |
| City : Many Locations |
| Country : Saudi Arabia |
| Status : Not yet recruiting |
| City : Many Locations |
| Country : Slovenia |
| Status : Recruiting |
| City : Many Locations |
| Country : United Arab Emirates |
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