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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000323-33 | EudraCT Number | ||
| U1111-1133-2156 | Other Identifier | WHO - Universal Trial Number (UTN) |
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Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient levels. In a person with haemophilia, the clotting process is much slower and the person experiences bleeding episodes that can result in serious problems and potential disability.
The current haemophilia standard of care is to maintain FVIII activity level above 1%. Sometimes, patients can develop antibodies (so called "inhibitors") against FVIII and it is no longer effective at controlling bleeds. Bleeds in these patients are currently treated using other proteins involved in the clotting process.
The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds in "inhibitor" patients. This study consists of two parts, A and B. The purpose of part A is to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The purpose of part B is to confirm efficacy and safety of the dose found in part A in all participating patients (confirmatory part). Part B is expected to last 12-32 months.
Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6 months, will participate in this study.
Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be required to keep an electronic diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY86-6150 | Drug | Four dose levels (6.5 µg/kg, 20 µg/kg, 50 µg/kg and 90 µg/kg) of BAY86-6150 will be studied. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful treatments of bleeding episodes. | A bleed was defined as successfully treated, if no administration of rescue medication was required. | 10 hours after each bleed |
| Proportion of successful treatments of bleeding episodes on subject level. | Proportion of successful treatments of bleeding episodes was calculated as number of bleeding episodes treated successfully - without rescue medication - divided by the total number of bleeding episodes on a dose level. | 10 hours after each bleed |
| Measure | Description | Time Frame |
|---|---|---|
| Time to stop the bleed | 10 hours after each bleed | |
| Number of injections needed to stop the bleeding episode. | 10 hours after each bleed | |
| Effectiveness of treatment as rated by the subject's assessment (very effective, effective, partially effective, not effective). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacramento | California | 95817 | United States | |||
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| eptacog alfa [activated] | Drug | comparative PK/PD (pharmacokinetics/pharmacodynamics) evaluation |
|
| BAY86-6150 | Drug | Confirmation of recommended dose of BAY86-6150 to be evaluated further as determined in Part A. |
|
| 10 hours after each bleed |
| Participant's reported outcome as assessed by Euro QoL (EQ-5D). | 14 days after last exposure to BAY86-6150 |
| Participant's reported outcome as assessed by Brief Pain Inventory. | 7 days after last exposure to BAY86-6150 |
| Participant's reported outcome as assessed by Work Productivity and Activity Impairment Questionaire. | 14 days after last exposure to BAY86-6150 |
| Chattanooga |
| Tennessee |
| 37403 |
| United States |
| Melbourne | Victoria | Australia |
| Rio de Janeiro | Rio de Janeiro | 20211030 | Brazil |
| São Paulo | São Paulo | 01401901 | Brazil |
| São Paulo | São Paulo | 04023-061 | Brazil |
| Sofia | 1756 | Bulgaria |
| Santiago | 836-0156 | Chile |
| Guangzhou | Guangdong | 510515 | China |
| Beijing | 100730 | China |
| Tianjin | China |
| Barranquilla | Atlántico | Colombia |
| Bogotá | Colombia |
| Aarhus N | 8200 | Denmark |
| Lyon | 69437 | France |
| Tours | 37044 | France |
| Villingen-Schwenningen | Baden-Wurttemberg | 78050 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Budapest | 1134 | Hungary |
| Debrecen | 4032 | Hungary |
| Hyderabad | Andhra Pradesh | 500034 | India |
| Ludhiana | Punjab | 141008 | India |
| Bangalore | 34 | India |
| Pune | 411004 | India |
| Tel Litwinsky | 5262000 | Israel |
| Florence | 50134 | Italy |
| Milan | 20122 | Italy |
| Kashihara | Nara | 634-8522 | Japan |
| Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Suginami | Tokyo | 167-0035 | Japan |
| Guadalajara | Jalisco | Mexico |
| Oaxaca City | Oaxaca | 68000 | Mexico |
| San Luis Potosí City | San Luis Potosí | 78216 | Mexico |
| México D. F. | 04530 | Mexico |
| Utrecht | 3508 GA | Netherlands |
| Christchurch | 8011 | New Zealand |
| Warsaw | 02-776 | Poland |
| Timișoara | Timiș County | 300011 | Romania |
| Bucharest | 022328 | Romania |
| Bucharest | 11026 | Romania |
| Khabarovsk | 680009 | Russia |
| Saint Petersburg | 191186 | Russia |
| Samara | 443079 | Russia |
| Yekaterinburg | 620149 | Russia |
| Singapore | 119228 | Singapore |
| Singapore | 169608 | Singapore |
| Bloemfontein | Freestate | South Africa |
| Johannesburg | Gauteng | 2132 | South Africa |
| Pretoria | Gauteng | 0001 | South Africa |
| Seoul | 134-727 | South Korea |
| Gothenburg | 413 45 | Sweden |
| Taipei | Taipei | 10016 | Taiwan |
| Changhua | 500 | Taiwan |
| Taipei | 110 | Taiwan |
| Istanbul | 34098 | Turkey (Türkiye) |
| Izmir | 35100 | Turkey (Türkiye) |
| Donetsk | 83045 | Ukraine |
| Lviv | 79044 | Ukraine |
| Odesa | 65025 | Ukraine |
| London | SE1 7EH | United Kingdom |
| Truro | TR1 3LJ | United Kingdom |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
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| ID | Term |
|---|---|
| D005167 | Factor VII |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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