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| ID | Type | Description | Link |
|---|---|---|---|
| STH-OCT-2016-01 | Other Identifier | AEMPS |
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
| Instituto de Investigación Hospital Universitario La Paz | OTHER |
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The purpose of this study is to describe the pharmacokinetic profile of patients with hemophilia A in prophylaxis in Spain using myPKFit®
This pharmacokinetic profile will be obtained in only in patient using Advate® (INN-octocog alfa) or Adynovi® (INN- rurioctocog alfa pegol), both recombinant intravenous FVIII products, with myPKFiT®. This patients will be followed during the period of 12 months, and the pharmacokinetic will be measured collecting at least 2 blood samples, in which the presence of factor VIII will be determined by the usual clinical methods: chromogenic method or coagulative method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemophilia A patients | Group of patients in prophylactic treatment with Advate® (octocog alfa) or Adynovi® (rurioctocog alfa pegol), or patients using already myPKFit®. Patients will be given a dose of octocog alfa or rurioctocog alfa pegol according to usual clinical practice, and two blood samples will be taken in case of octocog alfa: one sample will be extracted 3-4h postdose (+/- 30 minutes), and the second sample will be extracted 24-32h postdose (+/- 60 minutes). In case of rurioctocog alfa pegol, the first sample is taken in the same conditions than octocog alfa, and the second sample will be extracted 48h postdose (+/- 120 minutes), and other sample post 72h(+/- 120 minutes) optional. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| octocog alfa | Drug | Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile: FVIII half-life measured with MyPKFiT | Change from Baseline to 12 months | 3-4 hours postdose +/- 30 minutes |
| Pharmacokinetic profile: FVIII half-life measured with MyPKFiT | Change from Baseline to 12 months | 24-32 hours postdose +/- 60 minutes |
| Pharmacokinetic profile: FVIII half-life measured with MyPKFiT | Change from Baseline to 12 months | 48 hours postdose +/- 60 minutes |
| Pharmacokinetic profile: FVIII half-life measured with MyPKFiT | Change from Baseline to 12 months | 72 hours postdose |
| Pharmacokinetic profile: Clearance measured with MyPKFiT | Change from Baseline to 12 months | 3-4 hours postdose +/- 30 minutes |
| Pharmacokinetic profile: Clearance measured with MyPKFiT | Change from Baseline to 12 months | 24-32 hours postdose +/- 60 minutes |
| Pharmacokinetic profile: Clearance measured with MyPKFiT | Change from Baseline to 12 months | 48 hours postdose +/- 60 minutes |
| Pharmacokinetic profile: Clearance measured with MyPKFiT |
| Measure | Description | Time Frame |
|---|---|---|
| Hemorrhagic risk of physical activity | Measured with Broderick scale | baseline |
| Hemorrhagic risk of physical activity | Measured with Broderick scale |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with hemophilia A on prophylactic treatment with Advate® or Adynovi®
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| Name | Affiliation | Role |
|---|---|---|
| M Teresa Álvarez Román, MD,PhD | Hospital Universitario La Paz, IdiPAZ, Universidad Autónoma de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complexo Hospitalario Universitario A Coruña | A Coruña | A Coruña | 15006 | Spain | ||
| Hospital Universitario Son Espases |
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Whole blood samples collected in citrate plasma tubes to separate it and measure FVIII:chromogenic and FVIII:one stage
| rurioctocog alfa pegol | Drug | Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software |
|
|
Change from Baseline to 12 months
| 72 hours postdose |
| Pharmacokinetic profile: Volume in steady state measured with MyPKFiT | Change from Baseline to 12 months | 3-4 hours postdose +/- 30 minutes |
| Pharmacokinetic profile: Volume in steady state measured with MyPKFiT | Change from Baseline to 12 months | 24-32 hours postdose +/- 60 minutes |
| Pharmacokinetic profile: Volume in steady state measured with MyPKFiT | Change from Baseline to 12 months | 48 hours postdose +/- 60 minutes |
| Pharmacokinetic profile: Volume in steady state measured with MyPKFiT | Change from Baseline to 12 months | 72 hours postdose |
| month 12 |
| Joint condition | Hemophilia Joint Health Score | baseline |
| Joint condition | Hemophilia Joint Health Score | month 12 |
| Number of total bleeding episodes in a year | Measured by annual bleeding record | baseline |
| Number of total bleeding episodes in a year | Measured by annual bleeding record | month 12 |
| Annual Joint Bleeding Record | Hemophilia Joint Health Score | baseline |
| Annual Joint Bleeding Record | Hemophilia Joint Health Score | month 12 |
| Self-adherence to treatment evaluation | Measured by VERITAS- PRO scale | month 12 |
| Adverse Events | Collect and identify adverse events | baseline |
| Adverse Events | Collect and identify adverse events | month 12 |
| Palma |
| Balearic Islands |
| 07120 |
| Spain |
| Hospital Sant Joan de Deu | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Hospital Universitario Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
| Hospital Virgen del Camino | Pamplona | Navarre | 31008 | Spain |
| Hospital Xeral de Vigo | Vigo | Pontevedra | 36212 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitario Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital Vall D'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Regional Universitario de Málaga | Málaga | 29010 | Spain |
| Hospital Materno-infantil de Málaga | Málaga | 29011 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D006395 | Hemarthrosis |
| 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 |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C078147 | F8 protein, human |
| D005169 | Factor VIII |
| C000609799 | BAX 855 |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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