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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000117-29 | EudraCT Number |
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This is the first in humans study of BAY86-6150 (B0189) in non-bleeding subjects with moderate or severe congenital hemophilia A or B with or without inhibitors. This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study. It is designed to investigate the safety, tolerability, potential immunogenicity, pharmacokinetic and pharmacodynamic profile of BAY86-6150 (B0189) and to determine a dose or range of doses to be examined in subsequent studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY Factor VII (6.5 µg/kg) / Placebo | Experimental | n = 4, randomized 3:1; 6.5 µg/kg BAY 86-6150 (B0189):Placebo |
|
| BAY Factor VII (20 µg/kg) / Placebo | Experimental | n = 4, randomized 3:1; 20 µg/kg BAY 86-6150 (B0189):Placebo |
|
| BAY Factor VII (50 µg/kg) / Placebo | Experimental | n = 4, randomized 3:1; 50 µg/kg BAY 86-6150 (B0189):Placebo |
|
| BAY Factor VII (90 µg/kg) / Placebo | Experimental | n = 4, randomized 3:1; 90 µg/kg BAY 86-6150 (B0189):Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY Factor VII (BAY86-6150) | Drug | BAY Factor VII (BAY86-6150), 6.5 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Up to Day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic assessment, based on plasma concentration of BAY86-6150 | 9 time points from pre-dosing on Day 1 up to 48 hours post-dosing | |
| Pharmacodynamic assessment, based on plasma hemostasis marker level | 9 time points from pre-dosing on Day 1 up to 48 hours post-dosing |
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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 |
|---|---|---|---|---|---|---|
| Warsaw | 02-776 | Poland | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22353395 | Result | Mahlangu JN, Coetzee MJ, Laffan M, Windyga J, Yee TT, Schroeder J, Haaning J, Siegel JE, Lemm G. Phase I, randomized, double-blind, placebo-controlled, single-dose escalation study of the recombinant factor VIIa variant BAY 86-6150 in hemophilia. J Thromb Haemost. 2012 May;10(5):773-80. doi: 10.1111/j.1538-7836.2012.04667.x. |
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| BAY Factor VII (BAY86-6150) | Drug | BAY Factor VII (BAY86-6150), 20 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1. |
|
| BAY Factor VII (BAY86-6150) | Drug | BAY Factor VII (BAY86-6150), 50 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1. |
|
| BAY Factor VII (BAY86-6150) | Drug | BAY Factor VII (BAY86-6150), 90 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1. |
|
| Placebo | Drug | Placebo will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1. |
|
| Immunogenicity assessment, based on anti-BAY86-6150 binding antibody levels | 3 time points from pre-dosing on Day 1 up to Day 50 |
| Bloemfontein |
| Freestate |
| 9300 |
| South Africa |
| Johannesburg | Gauteng | 2193 | South Africa |
| London | W12 0HS | 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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