Tracking Information
| Start Date ICMJE | June 2008 |
|---|---|
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE (submitted: April 2, 2009) | Efficacy and Safety of Kogenate Bayer/FS [ Time Frame: After 12 months, after 24 months ] [ Designated as safety issue: Yes ] |
| Change History | Complete list of historical versions of study NCT00874926 on ClinicalTrials.gov Archive Site |
Descriptive Information
| Brief Title ICMJE | EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS |
|---|---|
| Official Title ICMJE | 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. |
| Detailed Description | |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Cohort, Prospective |
| Condition ICMJE | Haemophilia A |
| Intervention ICMJE | Drug: Kogenate (BAY14-2222) Haemophilia A patients |
| Study Arms / Comparison Groups | Group 1 Intervention: Drug: Kogenate (BAY14-2222) |
Recruitment Information
| Estimated Enrollment ICMJE | 350 | ||||
|---|---|---|---|---|---|
| Estimated Completion Date | December 2011 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Bahrain, Bosnia and Herzegovina, Croatia, Germany, Israel, Kazakhstan, Kuwait, Libyan Arab Jamahiriya, Morocco, Oman, Qatar, Romania, Russian Federation, Saudi Arabia, Slovenia, Tunisia, United Arab Emirates |
Administrative Information
| NCT ID ICMJE | NCT00874926 | ||||
|---|---|---|---|---|---|
| Responsible Party | Global Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG | ||||
| Study ID Numbers ICMJE | 13405, KG 0702 | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Bayer |