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This study will determine the efficacy of human-cl rhFVIII in previously treated patients with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in surgical prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| human cl-rhFVIII | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant Factor VIII | Biological | intravenous infusion of factor FVIII every other day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months | Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment. | At least 50 Exposure Days and at least 6 months |
| Efficacy of Treating Bleeding Episodes | At the end of a bleeding episode, efficacy was assessed as:
| After each bleeding episode, up to 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Oldenburg, Prof. | Universitaetsklinikum Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universitaet Wien | Vienna | 1090 | Austria | |||
| Haematological Hospital Joan Pavel |
36 participants were enrolled and screened. 4 were screen failures. Therefore, 32 of the 36 enrolled were exposed to investigation product.
Participants were enrolled at 11 European sites beginning June 2010 and completing in January 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Human Cl-rhFVIII | recombinant Factor VIII : intravenous infusion of factor FVIII every other day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Human Cl-rhFVIII | recombinant Factor VIII : intravenous infusion of factor FVIII every other day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months | Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment. | All subjects who started prophylactic treatment were evaluated. | Posted | Mean | Standard Deviation | Bleeds per month | At least 50 Exposure Days and at least 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 | Human Cl-rhFVIII | recombinant Factor VIII : intravenous infusion of factor FVIII every other day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Traumatic fracture | Injury, poisoning and procedural complications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sigurd Knaub | Octapharma AG | 41 55 451 21 41 | sigurd.knaub@octapharma.ch |
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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 |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Sofia |
| 1233 |
| Bulgaria |
| Werlhof Institut fuer Haemostaseologie GmbH | Hanover | Lower Saxony | 30159 | Germany |
| Universitaetsklinikum | Bonn | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| SRH Kurpfalzkrankenhaus Heidelberg | Heidelberg | 69123 | Germany |
| Basingstoke & North Hampshire NHS Foundation Trust | Basingstoke | RG24 9NA | United Kingdom |
| University Hospital of Wales | Cardiff | United Kingdom |
| Royal Free Hospital | London | United Kingdom |
| Manchester Royal Infirmary | Manchester | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | United Kingdom |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Efficacy of Treating Bleeding Episodes | At the end of a bleeding episode, efficacy was assessed as:
| Posted | Number | Percentage of treatments | After each bleeding episode, up to 6 month | bleeding episodes | bleeding episodes |
|
|
|
| 2 |
| 32 |
| 3 |
| 32 |
| STATUS EPILEPTICUS | Nervous system disorders |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders |
|
| Contusion | Injury, poisoning and procedural complications |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Paraesthesia | Nervous system disorders |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
|
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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 |