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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005253-39 | EudraCT Number |
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A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw | Experimental | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week) |
|
| rFVIII-FS (Kogenate FS, BAY14-2222), biw (30 IU/kg + 40 IU/kg) | Experimental | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week) |
|
| rFVIII-FS (Kogenate FS, BAY14-2222), tiw (3 x 25 IU/kg) | Experimental | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week | Drug | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period | Up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Bleeds Per Participant During the 9-month Treatment Period | Up to 9 months | |
| Number of Participants With Bleeding Events During the 9-month Treatment Period | Up to 9 months | |
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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 |
|---|---|---|---|---|---|---|
| Kirov | 610 027 | Russia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | V.V. Vdovin, T.A. Andreeva, T.A. Chernova, F.G. Perina, E.E.M. Shiller, P.V. Svirin, M. Maas Enriquez, and S. Rauchensteiner. Prophylaxis with Once, Twice or Three-Times Weekly Dosing of rFVIII-FS Prevents Joint Bleeds in a Previously Treated Pediatric Population with Moderate/Severe Hemophilia A. Journal of Coagulation Disorders 2011; 3:(1). October 2011 |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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There was an indefinite time period between screening and baseline. Study treatment started at visit 2 (baseline).
The recruitment period took from first patient first visit 28 Jun 2007 to last patient first visit 26 Dec 2008. The study period took from first patient first visit 28 Jun 2007 to last patient last visit 27 Sep 2009. All 4 sites were medical clinics. Assignment to a group was based on patients previous treatment schedule (non-randomized).
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| ID | Title | Description |
|---|---|---|
| FG000 | rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week) |
| FG001 | rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg) | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week) |
| FG002 | rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg) | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week) |
| 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 | Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period | Posted | Number | Percentage of participants | Up to 9 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 | rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Factor VIII inhibition | Blood and lymphatic system disorders | MedDRA version 13.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adenoiditis | Infections and infestations | MedDRA version 13.0 | Non-systematic Assessment |
Protocol deviations were not excluded: e.g. a previously untreated patient developed the transitory inhibitor; change to a higher group did not always occur according protocol; there was temporary lack of smaller vial sizes at the centers.
| 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 |
|---|---|
| C438308 | recombinant FVIII, sugar formulated |
| C078147 | F8 protein, human |
| C414350 | BAY 14-2222 |
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|
| rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg) | Drug | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week) |
|
| rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg) | Drug | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for patients in this group |
|
| Number of Participants With Joint Bleeds During the 9-month Treatment Period |
| Up to 9 months |
| Number of Participants in Each Group at the End of the Study | Up to 9 months |
| Actual Monthly rFVIII-FS Consumption | Up to 9 months |
| Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment | The assessment of joint function using Stockholm Joint Score. The minimum value is 0 (the best condition), and the maximum value is 140 (the worst condition). | baseline and 9 months |
| Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group) | Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition). | 9 months |
| Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment | Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition). | 9 months |
| Moscow |
| 105077 |
| Russia |
| Saint Petersburg | 191186 | Russia |
| Yekaterinburg | 620149 | Russia |
| BG001 |
| rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg) |
rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week) |
| BG002 | rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg) | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity | Number | participants |
|
| Body Weight | Mean | Standard Deviation | Kilograms |
|
| Height | Mean | Standard Deviation | Centimeters |
|
| Number of participants on Prophylaxis Prior to Screening | Number of participants on prophylaxis versus on-demand therapy before screening | Number | pariticipants |
|
| FVIII trough level at Baseline | Mean | Standard Deviation | Percentage of FVIII activity |
|
| Number of participants with different exposure days (ED) | Number | participants |
|
| Percentage of participants with Target Joint Present | Number | Percentage of participants |
|
| Number of participants with bleeding rates in previous 6-9 Months | Number | participants |
|
| Stockholm Joint Score | The assessment of joint function using Stockholm Joint Score. The minimum value is 0 (the best condition), and the maximum value is 140 (the worst condition). | Mean | Standard Deviation | scores on a scale |
|
| OG002 | rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg) | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group |
|
|
| Secondary | Number of Bleeds Per Participant During the 9-month Treatment Period | Posted | Median | Full Range | bleeds per participant | Up to 9 months |
|
|
|
| Secondary | Number of Participants With Bleeding Events During the 9-month Treatment Period | Posted | Number | Participants | Up to 9 months |
|
|
|
| Secondary | Number of Participants With Joint Bleeds During the 9-month Treatment Period | Posted | Number | Participants | Up to 9 months |
|
|
|
| Secondary | Number of Participants in Each Group at the End of the Study | Participants were allowed to switch treatment groups upon occurrence of joint bleed. Therefore the number of participants per group at the end of the study is different from the number of participants per group at baseline. | Posted | Number | Participants | Up to 9 months |
|
|
|
| Secondary | Actual Monthly rFVIII-FS Consumption | Posted | Mean | Standard Deviation | IU/kg | Up to 9 months |
|
|
|
| Secondary | Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment | The assessment of joint function using Stockholm Joint Score. The minimum value is 0 (the best condition), and the maximum value is 140 (the worst condition). | Posted | Mean | Standard Deviation | Scores on a scale | baseline and 9 months |
|
|
|
| Secondary | Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group) | Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition). | Participants who completed the questionnaire. | Posted | Mean | Standard Deviation | Scores on a scale | 9 months |
|
|
|
| Secondary | Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment | Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition). | Participants who completed the questionnaire. | Posted | Mean | Standard Deviation | Scores on a scale | 9 months |
|
|
|
| 1 |
| 11 |
| 4 |
| 11 |
| EG001 | rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg) | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week) | 2 | 13 | 3 | 13 |
| EG002 | rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg) | rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group | 0 | 8 | 3 | 8 |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 13.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 13.0 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA version 13.0 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA version 13.0 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA version 13.0 | Non-systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA version 13.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA version 13.0 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA version 13.0 | Non-systematic Assessment |
|
| Yersinia infection | Infections and infestations | MedDRA version 13.0 | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA version 13.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.0 | Non-systematic Assessment |
|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.0 | Non-systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.0 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA version 13.0 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA version 13.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA version 13.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 13.0 | Non-systematic Assessment |
|
The Institute shall supply a draft of any intended publication to the Customer not less than 60 (sixty) days before submission it for the publication in question and will supply a draft of any abstract or detailed paper or oral statement intended for public presentation not less than 60 (sixty) days before the earliest of the date of submission of the abstract or delivery of the public presentation. The Institute agrees that in any such publication only such data as is contained in an analysis.
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Title | Measurements |
|---|---|
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