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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012149-43 | EudraCT Number |
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The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study will compare 2 different methods (assays) for measuring the amount of study drug, the chromogenic substrate assay per European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ). During one six month period patients will receive the study drug where the dose has been measured using the" (CS/EP) and during the other six months period the dose will be measured based on the Chromogenic Substrate Adjusted assay CS/ADJ)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Recombinant Factor VIII (BAY81-8973) then Kogenate FS | Experimental | Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between |
|
| Arm 2: Kogenate FS then Recombinant Factor VIII (BAY81-8973) | Experimental | Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between |
|
| Arm 3: Recombinant Factor VIII by CS/EP then by CS/ADJ | Experimental | Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months |
|
| Arm 4: Recombinant Factor VIII by CS/ADJ then by CS/EP | Experimental | Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia for 6 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Factor VIII (BAY81-8973) | Biological | Single dose of BAY81-8973 crossed over to single dose of Kogenate FS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A - Area Under the Drug Concentration-time Curve (AUC) | To examine the Pharmacokinetic (PK) characteristics of BAY 81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay. | Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection. AUC calculated from time of injection to infinity. |
| Part A - Half-life (t 1/2) | To examine the PK characteristics of BAY81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay. | Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection. |
| Part B - Annualized Number of Total Bleeds | The annualized number of bleeds experienced by participants | 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Part B - The in Vivo Recovery Values of Human Factor VIII (FVIII) | The amount of Factor VIII found in blood samples taken after the injection of the study drug at the beginning of the CS/EP treatment period. | 15-30 minutes after the injection |
| Part B - Annualized Number of Bleeds in Each 6-month Potency Assignment Period |
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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 |
|---|---|---|---|---|---|---|
| Orange | California | 92868 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27002680 | Result | Kitchen S, Katterle Y, Beckmann H, Maas Enriquez M. Chromogenic assay for BAY 81-8973 potency assignment has no impact on clinical outcome or monitoring in patient samples. J Thromb Haemost. 2016 Jun;14(6):1192-9. doi: 10.1111/jth.13322. Epub 2016 May 3. | |
| 26931631 | Result | Oldenburg J, Windyga J, Hampton K, Lalezari S, Tseneklidou-Stoeter D, Beckmann H, Maas Enriquez M. Safety and efficacy of BAY 81-8973 for surgery in previously treated patients with haemophilia A: results of the LEOPOLD clinical trial programme. Haemophilia. 2016 May;22(3):349-53. doi: 10.1111/hae.12839. Epub 2016 Mar 1. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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14 participants were enrolled in each of Arms 1 and 2 in Part A. Of these, 11 participants continued into each of Arms 3 and 4 in Part B. Arm 3 enrolled 20 and Arm 4 enrolled 21 additional participants who had not participated in Part A. Arm 5 enrolled 5 participants specifically for surgery in Part C who had not participated in Parts A or B.
Participants were recruited from specialized hemophilia treatment centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Recombinant Factor VIII (BAY81-8973) Then Kogenate FS | Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A Treatment Period |
|
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|
| Arm 5: Recombinant Factor VIII by CS/EP | Experimental | Part C - Arm 5: Participants received a loading dose of approximately 50 IU/kg of BAY 81-8973 before the first surgical incision followed by further treatment with BAY 81-8973 according to surgical requirements for up to 3 weeks |
|
| Recombinant Factor VIII (Kogenate FS, BAY14-2222) | Biological | Single dose of Kogenate FS crossed over to Single dose of BAY81-8973 |
|
| Recombinant Factor VIII (BAY81-8973) | Biological | Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization. |
|
| Recombinant Factor VIII (BAY81-8973) | Biological | Participants received a loading dose of approximately 50 IU/kg of BAY 81-8973 before the first surgical incision followed by further treatment with BAY 81-8973 according to surgical requirements for up to 3 weeks |
|
The annualized number of bleeds experienced by participants in each of the two treatment periods |
| 6 months on each potency |
| Part B - Control of Bleeding as Measured by the Number of Injections Required to Treat a Bleed | The number of injections needed by participants to stop a bleed | 6 months on each potency |
| Part B - Changes From Baseline at 12 Months in Quality of Life (QoL) as Measured by Transformed Total Score of Haemo-QoL Questionnaire | A measure of how treatment with BAY81-8973 affected the daily life of participants. the scoring system has 100 points. 0 is the worst possible score. 100 is the best possible score. Positive changes from baseline indicate an improvement in quality of life and negative changes indicate a deterioration. | Baseline and 12 months |
| Part B - Changes From Baseline at 12 Months in Utility Index as Measured by EQ-5D Questionaire | A measure of how treatment with BAY81-8973 affected the daily life of participants. 1.0 = Best possible score, -0.594 = Worst possible score. Positive changes from baseline indicate an improvement and negative changes indicate a deterioration. | Baseline and 12 months |
| Part A - Number of Participants With Inhibitory Antibody Formation | A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973 | Up to 6 weeks after first injection of study drug |
| Part B - Number of Participants With Incidence of Inhibitory Antibody Formation | A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973 | Up to 12 months after drug administration |
| Part C - Number of Participants With Incidence of Inhibitory Antibody Formation | A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973 | before and 3 weeks after surgery |
| Part A - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70) | A test to analyze the formation of antibodies to HSP-70 | Up to 6 weeks after drug administration |
| Part B - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70) | A test to analyze the formation of antibodies to HSP-70 | Up to 12 months after drug administration |
| Part C - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70) | A test to analyze the formation of antibodies to HSP-70 | before and 3 weeks after surgery |
| Part A - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP) | A test to ensure that participants have not developed antibodies to HCP during the study | Up to 4 weeks after drug administration |
| Part B - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP) | A test to ensure that participants have not developed antibodies to HCP during the study | Up to 12 months after drug administration |
| Part C - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP) | A test to ensure that participants have not developed antibodies to HCP during the study | before and 3 weeks after surgery |
| Part B - Number of Participants With Assessment of the Hemostasis During Major Surgery | An assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operations | An average of 1 month after start of treatment |
| Part C - Number of Participants With Assessment of the Hemostasis During Major Surgery | An assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operations | at the time of surgery |
| Sacramento |
| California |
| 95817 |
| United States |
| Tampa | Florida | 33607 | United States |
| Boston | Massachusetts | 02115 | United States |
| East Lansing | Michigan | 48823 | United States |
| Kansas City | Missouri | 64108-9898 | United States |
| Cleveland | Ohio | 44106-2602 | United States |
| BahÃa Blanca | Buenos Aires | B8001HXM | Argentina |
| Rosario | Santa Fe Province | S2000CKF | Argentina |
| Vienna | State of Vienna | 1090 | Austria |
| Graz | 8036 | Austria |
| Zagreb | 10000 | Croatia |
| DK-Aarhus N | 8200 | Denmark |
| Frankfurt am Main | Hesse | 60596 | Germany |
| Bonn | North Rhine-Westphalia | 53127 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Homburg | Saarland | 66421 | Germany |
| Magdeburg | Saxony-Anhalt | 39112 | Germany |
| Hong Kong | Hong Kong |
| Bangalore | 34 | India |
| Mumbai | 400012 | India |
| Pune | 411005 | India |
| Jakarta | 10430 | Indonesia |
| Ramat Gan | 5262000 | Israel |
| Catanzaro | Calabria | 88100 | Italy |
| Naples | Campania | 80131 | Italy |
| Naples | Campania | 80144 | Italy |
| Rome | Lazio | 00168 | Italy |
| Milan | Lombardy | 20122 | Italy |
| Vicenza | Veneto | 36100 | Italy |
| Oslo | 0027 | Norway |
| Karachi | 75300 | Pakistan |
| Krakow | 31-501 | Poland |
| Warsaw | 02-776 | Poland |
| Belgrade | 11000 | Serbia |
| Niš | 18000 | Serbia |
| Novi Sad | 21000 | Serbia |
| Pretoria | Gauteng | 0001 | South Africa |
| Parktown | 2132 | South Africa |
| A Coruña | A Coruña | 15006 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Santander | Cantabria | 39008 | Spain |
| Jaén | Jaén | 23007 | Spain |
| Oviedo | Principality of Asturias | 33006 | Spain |
| Valencia | Valencia | 46026 | Spain |
| Gothenburg | 413 45 | Sweden |
| Malmö | 205 02 | Sweden |
| Karolinska Universitetssjukhuset i Solna | Stockholm | 171 76 | Sweden |
| Taipei | Taipei | 10016 | Taiwan |
| Changhua | 500 | Taiwan |
| Taipei | 11217 | Taiwan |
| Bangkok | 10330 | Thailand |
| Bangkok | 10400 | Thailand |
| Adana | 01330 | Turkey (Türkiye) |
| Antalya | 07059 | Turkey (Türkiye) |
| Izmir | 35-100 | Turkey (Türkiye) |
| Dundee | Dundee City | DD1 9SY | United Kingdom |
| Oxford | Oxfordshire | OX3 7LJ | United Kingdom |
| Sheffield | South Yorkshire | S10 2JF | United Kingdom |
| London | SE1 7EH | United Kingdom |
| 27339736 | Derived | Saxena K, Lalezari S, Oldenburg J, Tseneklidou-Stoeter D, Beckmann H, Yoon M, Maas Enriquez M. Efficacy and safety of BAY 81-8973, a full-length recombinant factor VIII: results from the LEOPOLD I trial. Haemophilia. 2016 Sep;22(5):706-12. doi: 10.1111/hae.12952. Epub 2016 Jun 24. |
| Arm 2: Kogenate FS Then Recombinant Factor VIII (BAY81-8973) |
Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between |
| FG002 | Arm 3: Recombinant Factor VIII by CS/EP Then by CS/ADJ | Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months |
| FG003 | Arm 4: Recombinant Factor VIII by CS/ADJ Then by CS/EP | Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia (CS/EP) for 6 months |
| FG004 | Arm 5: Recombinant Factor VIII by CS/EP | Part C - Arm 5: Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks |
| FG005 | Arm 6: Recombinant Factor VIII (BAY81-8973) Part B + Extension | Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and CS/ADJ for 6 months sequence according to randomization and up to 12 months (CS/EP) during extension |
| Participants Received Treatment |
|
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Part A Follow up Period |
|
| Part B Treatment Period |
|
|
| Part B Follow up Period |
|
| Extension Period |
|
|
| Part C Treatment Period |
|
| Part C Follow up Period |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Recombinant Factor VIII (BAY81-8973) Then Kogenate FS | Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between |
| BG001 | Arm 2: Kogenate FS Then Recombinant Factor VIII (BAY81-8973) | Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between |
| BG002 | Arm 3: Recombinant Factor VIII by CS/EP Then by CS/ADJ | Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months |
| BG003 | Arm 4: Recombinant Factor VIII by CS/ADJ Then by CS/EP | Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia for 6 months |
| BG004 | Arm 5: Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C | Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Part A based on pharmacokinetic (PK) analysis set; Parts B and C based on safety analysis set | Number | Participants |
| |||||||||||||||
| Sex/Gender, Customized | Part A based on PK analysis set; Parts B and C based on safety analysis set | Number | Participants |
| |||||||||||||||
| Most recent treatment before enrolment in the study | Parts A, B and C all based on safety analysis set | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part A - Area Under the Drug Concentration-time Curve (AUC) | To examine the Pharmacokinetic (PK) characteristics of BAY 81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay. | PK Analysis Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Int.units x hours/deciliters (IU*h/dL) | Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection. AUC calculated from time of injection to infinity. |
|
|
| ||||||||||||||||||||||||||||
| Primary | Part A - Half-life (t 1/2) | To examine the PK characteristics of BAY81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay. | PK Analysis Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours (h) | Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection. |
|
| |||||||||||||||||||||||||||||
| Primary | Part B - Annualized Number of Total Bleeds | The annualized number of bleeds experienced by participants | Intent to treat (ITT) | Posted | Median | Inter-Quartile Range | Bleeds | 12 months after randomization |
|
| |||||||||||||||||||||||||||||
| Secondary | Part B - The in Vivo Recovery Values of Human Factor VIII (FVIII) | The amount of Factor VIII found in blood samples taken after the injection of the study drug at the beginning of the CS/EP treatment period. | ITT. 1 measurement was taken in all participants at the start of the CS/EP labelled treatment period (CS/ADJ labelled treatment was experimental and will not be used for the future commercial drug, so no measurements were taken). Note: Only 59 of the 62 participants had valid recovery data. | Posted | Median | Inter-Quartile Range | Kg/dL | 15-30 minutes after the injection |
|
| |||||||||||||||||||||||||||||
| Secondary | Part B - Annualized Number of Bleeds in Each 6-month Potency Assignment Period | The annualized number of bleeds experienced by participants in each of the two treatment periods | ITT. Note: One participant in Part B did not receive any Recombinant Factor VIII measured by the CS/ADJ method, leading to 61 participants (not 62) in that group. | Posted | Median | Inter-Quartile Range | Bleeds | 6 months on each potency |
|
| |||||||||||||||||||||||||||||
| Secondary | Part B - Control of Bleeding as Measured by the Number of Injections Required to Treat a Bleed | The number of injections needed by participants to stop a bleed | ITT. Note: One participant in Part B did not receive any Recombinant Factor VIII measured by the CS/ADJ method, leading to 61 participants (not 62) in that group. | Posted | Median | Full Range | Injections | 6 months on each potency | Bleeds | Participants |
|
| |||||||||||||||||||||||||||
| Secondary | Part B - Changes From Baseline at 12 Months in Quality of Life (QoL) as Measured by Transformed Total Score of Haemo-QoL Questionnaire | A measure of how treatment with BAY81-8973 affected the daily life of participants. the scoring system has 100 points. 0 is the worst possible score. 100 is the best possible score. Positive changes from baseline indicate an improvement in quality of life and negative changes indicate a deterioration. | ITT. Note: Only 51 of the 62 participants had data available for the 12-month QoL analysis. | Posted | Median | Full Range | Scores on a scale | Baseline and 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Part B - Changes From Baseline at 12 Months in Utility Index as Measured by EQ-5D Questionaire | A measure of how treatment with BAY81-8973 affected the daily life of participants. 1.0 = Best possible score, -0.594 = Worst possible score. Positive changes from baseline indicate an improvement and negative changes indicate a deterioration. | ITT. Note: Only 61 of the 62 participants had data available for the Utility Index of the EQ-5D questionnaire at Month 12. | Posted | Median | Full Range | Scores on a scale | Baseline and 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Part A - Number of Participants With Inhibitory Antibody Formation | A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973 | Safety population | Posted | Number | Participants | Up to 6 weeks after first injection of study drug |
|
| ||||||||||||||||||||||||||||||
| Secondary | Part B - Number of Participants With Incidence of Inhibitory Antibody Formation | A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973 | Safety population | Posted | Number | Participants | Up to 12 months after drug administration |
|
| ||||||||||||||||||||||||||||||
| Secondary | Part C - Number of Participants With Incidence of Inhibitory Antibody Formation | A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973 | ITT | Posted | Number | Participants | before and 3 weeks after surgery |
|
| ||||||||||||||||||||||||||||||
| Secondary | Part A - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70) | A test to analyze the formation of antibodies to HSP-70 | Safety population | Posted | Number | Participants | Up to 6 weeks after drug administration |
|
| ||||||||||||||||||||||||||||||
| Secondary | Part B - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70) | A test to analyze the formation of antibodies to HSP-70 | ITT | Posted | Number | Participants | Up to 12 months after drug administration |
|
| ||||||||||||||||||||||||||||||
| Secondary | Part C - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70) | A test to analyze the formation of antibodies to HSP-70 | ITT | Posted | Number | Participants | before and 3 weeks after surgery |
|
| ||||||||||||||||||||||||||||||
| Secondary | Part A - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP) | A test to ensure that participants have not developed antibodies to HCP during the study | ITT | Posted | Number | Participants | Up to 4 weeks after drug administration |
|
| ||||||||||||||||||||||||||||||
| Secondary | Part B - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP) | A test to ensure that participants have not developed antibodies to HCP during the study | ITT | Posted | Number | Participants | Up to 12 months after drug administration |
|
| ||||||||||||||||||||||||||||||
| Secondary | Part C - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP) | A test to ensure that participants have not developed antibodies to HCP during the study | ITT | Posted | Number | Participants | before and 3 weeks after surgery |
|
| ||||||||||||||||||||||||||||||
| Secondary | Part B - Number of Participants With Assessment of the Hemostasis During Major Surgery | An assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operations | ITT | Posted | Number | Participants | An average of 1 month after start of treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Part C - Number of Participants With Assessment of the Hemostasis During Major Surgery | An assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operations | ITT | Posted | Number | Participants | at the time of surgery |
|
|
From the date of signing informed consent through study completion, i.e. 21 Dec 2009 to 14 Mar 2013
The objective of Part C was efficacy assessment of surgery hemostasis, not safety assessment. It was allowed to include the same patient for several surgeries and for each surgery the patient was assigned a new patient number. Due to this approach, one patient with 3 surgeries was analyzed as 3 different patients, therefore the number at risk is 7.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Recombinant Factor VIII (BAY81-8973) - Part A | Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg | 0 | 27 | 0 | 27 | ||
| EG001 | Kogenate FS (BAY14-2222) - Part A | Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg | 0 | 28 | 1 | 28 | ||
| EG002 | Recombinant Factor VIII (BAY81-8973) Part B and Extension | Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and CS/ADJ for 6 months sequence according to randomization and up to 12 months (CS/EP) during extension | 12 | 62 | 43 | 62 | ||
| EG003 | Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C | Participants in Part C received a loading dose of approximately 50 IU/kg of BAY81-8973 (nearest whole vial amount) for less than 15 minutes before the first surgical incision. Then they received further treatment with BAY81-8973 according to surgical requirements up to 3 weeks. | 1 | 7 | 5 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Spinal pain | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Cephalhaematoma | Pregnancy, puerperium and perinatal conditions | MedDRA (15.1) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Somatoform disorder | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Miscarriage of partner | Social circumstances | MedDRA (15.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Thymus disorder | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pulmonary artery dilatation | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (15.1) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trial-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D025861 | Blood Coagulation Disorders, Inherited |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D005169 | Factor VIII |
| C078147 | F8 protein, human |
| C414350 | BAY 14-2222 |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
Not provided
Not provided
| Protocol Violation |
|
| starting another study |
|
| non-compliance |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Part A =/> 18 years |
|
| Part B < 18 years |
|
| Part B =/> 18 years |
|
| Part C < 18 years |
|
| Part C =/> 18 years |
|
| Part A - Male |
|
| Part B - Female |
|
| Part B - Male |
|
| Part C - Female |
|
| Part C - Male |
|
| Prophylaxis |
|
|
|
|
|
| Bleeds |
|
|
|
|
|
|
|
|
|
|
|
|
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