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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001362-10 | EudraCT Number |
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Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand treatment for children with severe Hemophilia A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Factor VIII | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Factor VIII (Kogenate FS, BAY14-2222) | Biological | Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period | Annualized bleedings period 1 minus period 2 ITT analysis set. | Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period | Annualized joint bleedings period 1 minus period 2 ITT analysis set. | Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment) |
| Difference of Intra-individual Change of Joint Function During Each Period Assessed by the Hemophilia Joint Health Score Between On-demand and Prophylaxis 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 |
|---|---|---|---|---|---|---|
| Guangzhou | Guangdong | 510515 | China | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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Of 33 participants who were screened for inclusion in the study, 30 were enrolled and received treatment.
Subject recruitment period was between 20-Mar-2013 to 28-Jun-2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rec. Factor VIII On-demand Followed by Prophylaxis | Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rec. Factor VIII On-demand Followed by Prophylaxis | Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period | Annualized bleedings period 1 minus period 2 ITT analysis set. | Posted | Median | 95% Confidence Interval | Bleeds | Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment) |
|
|
From first treatment through 3 days after the last dose of study drug, up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rec. Factor VIII On-demand Followed by Prophylaxis | Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 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 |
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|
Hemophilia Joint Health Score(HJHS) ranges from 0 to 124. Higher values in the HJHS represent worse situation for the subject. 2-sided Hodges Lehmann estimates for median 95% CI HJHS values difference of changes ITT analysis set. |
| From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment) |
| Wuhan |
| Hubei |
| 430022 |
| China |
| Beijing | 100730 | China |
| Beijing | China |
| Tianjin | China |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Baseline weight | Mean | Standard Deviation | Kg |
|
| Baseline body mass index | Mean | Standard Deviation | Kg/m2 |
|
| Target Joint for Bleeds | Number | Participants |
|
| Number of Target Joint | Number | Participants |
|
| Prior FVIII Treatment On-demand | Number | Participants |
|
| Number of Bleeds in Last 3 Months | Mean | Standard Deviation | Bleeds |
|
| Number of Joint Bleeds in Last 3 Months | Mean | Standard Deviation | Bleeds |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period | Annualized joint bleedings period 1 minus period 2 ITT analysis set. | Posted | Median | 95% Confidence Interval | Bleeds | Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment) |
|
|
|
| Secondary | Difference of Intra-individual Change of Joint Function During Each Period Assessed by the Hemophilia Joint Health Score Between On-demand and Prophylaxis Period | Hemophilia Joint Health Score(HJHS) ranges from 0 to 124. Higher values in the HJHS represent worse situation for the subject. 2-sided Hodges Lehmann estimates for median 95% CI HJHS values difference of changes ITT analysis set. | Posted | Median | 95% Confidence Interval | Scores on scale | From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment) |
|
|
|
| 0 |
| 30 |
| 2 |
| 30 |
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| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011498 |
| Protein Precursors |
| D001685 | Biological Factors |