Hemophilia A Clinical Trial
Official title:
Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using an Online Medical Application Based on a Published Population Model and a Bayesian Algorithm
Verified date | June 2023 |
Source | Spanish Society of Thrombosis and Haemostasis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to describe the pharmacokinetic profile of patients with hemophilia A in prophylaxis in Spain using myPKFit®
Status | Completed |
Enrollment | 50 |
Est. completion date | December 22, 2022 |
Est. primary completion date | December 22, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 1 Year to 65 Years |
Eligibility | Inclusion Criteria: - Male patients. - Age between 1 and 65 years old. - Patients diagnosed with Hemophilia A who are on prophylactic treatment with Advate® or Adynovi® or adjusted with myPKFIT. - Patients older than 18 who have signed the informed consent form. - In the case of mature minors, in addition to the consent signed by the legal guardian, an assent of the minor must be obtain. - In the case of patients legally incapable for giving their consent, their primary caregiver will consent as the patient's legal guardian. Exclusion Criteria: - Withdrawal of informed consent. - Patients with any medical or psychological condition that according to the researcher's criteria prevents them from following the usual clinical practice procedures. - Patients with concomitant diagnosis of other haemostasis disorders. - Patients being treated for induction of immunologic tolerance at the time of inclusion. |
Country | Name | City | State |
---|---|---|---|
Spain | Complexo Hospitalario Universitario A Coruña | A Coruna | A Coruña |
Spain | Hospital Universitario Cruces | Barakaldo | Vizcaya |
Spain | Hospital Vall D'Hebron | Barcelona | |
Spain | Hospital Universitario Virgen de la Arrixaca | El Palmar | Murcia |
Spain | Hospital Sant Joan de Deu | Esplugues de Llobregat | Barcelona |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Materno-infantil de Málaga | Malaga | |
Spain | Hospital Regional Universitario de Málaga | Malaga | |
Spain | Hospital Universitario Central de Asturias | Oviedo | Asturias |
Spain | Hospital Universitario Son Espases | Palma | Islas Baleares |
Spain | Hospital Virgen del Camino | Pamplona | Navarra |
Spain | Hospital Universitario Virgen del Rocío | Sevilla | |
Spain | Hospital Universitari i Politècnic La Fe | Valencia | |
Spain | Hospital Xeral de Vigo | Vigo | Pontevedra |
Lead Sponsor | Collaborator |
---|---|
Spanish Society of Thrombosis and Haemostasis | Instituto de Investigación Hospital Universitario La Paz, Takeda |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic profile: FVIII half-life measured with MyPKFiT | Change from Baseline to 12 months | 3-4 hours postdose +/- 30 minutes | |
Primary | Pharmacokinetic profile: FVIII half-life measured with MyPKFiT | Change from Baseline to 12 months | 24-32 hours postdose +/- 60 minutes | |
Primary | Pharmacokinetic profile: FVIII half-life measured with MyPKFiT | Change from Baseline to 12 months | 48 hours postdose +/- 60 minutes | |
Primary | Pharmacokinetic profile: FVIII half-life measured with MyPKFiT | Change from Baseline to 12 months | 72 hours postdose | |
Primary | Pharmacokinetic profile: Clearance measured with MyPKFiT | Change from Baseline to 12 months | 3-4 hours postdose +/- 30 minutes | |
Primary | Pharmacokinetic profile: Clearance measured with MyPKFiT | Change from Baseline to 12 months | 24-32 hours postdose +/- 60 minutes | |
Primary | Pharmacokinetic profile: Clearance measured with MyPKFiT | Change from Baseline to 12 months | 48 hours postdose +/- 60 minutes | |
Primary | Pharmacokinetic profile: Clearance measured with MyPKFiT | Change from Baseline to 12 months | 72 hours postdose | |
Primary | Pharmacokinetic profile: Volume in steady state measured with MyPKFiT | Change from Baseline to 12 months | 3-4 hours postdose +/- 30 minutes | |
Primary | Pharmacokinetic profile: Volume in steady state measured with MyPKFiT | Change from Baseline to 12 months | 24-32 hours postdose +/- 60 minutes | |
Primary | Pharmacokinetic profile: Volume in steady state measured with MyPKFiT | Change from Baseline to 12 months | 48 hours postdose +/- 60 minutes | |
Primary | Pharmacokinetic profile: Volume in steady state measured with MyPKFiT | Change from Baseline to 12 months | 72 hours postdose | |
Secondary | Hemorrhagic risk of physical activity | Measured with Broderick scale | baseline | |
Secondary | Hemorrhagic risk of physical activity | Measured with Broderick scale | month 12 | |
Secondary | Joint condition | Hemophilia Joint Health Score | baseline | |
Secondary | Joint condition | Hemophilia Joint Health Score | month 12 | |
Secondary | Number of total bleeding episodes in a year | Measured by annual bleeding record | baseline | |
Secondary | Number of total bleeding episodes in a year | Measured by annual bleeding record | month 12 | |
Secondary | Annual Joint Bleeding Record | Hemophilia Joint Health Score | baseline | |
Secondary | Annual Joint Bleeding Record | Hemophilia Joint Health Score | month 12 | |
Secondary | Self-adherence to treatment evaluation | Measured by VERITAS- PRO scale | month 12 | |
Secondary | Adverse Events | Collect and identify adverse events | baseline | |
Secondary | Adverse Events | Collect and identify adverse events | month 12 |
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