hemophilic arthropathy
Conditions
Interventions
People with hemophilia who are taking prophylaxis with emicizumab (n = 100) will be followed for a period of 2 to 12 years. They will be included in the study between Jan-2020 and Dec-2029, being foll
Drug
Sponsors
Universidade Federal de Minas Gerais
Universidade Federal de Minas Gerais
Eligibility
Inclusion criteria
Inclusion criteria: Any patient with AH who is going to use or is using MC-Ab may be included in the study, by clarifying and signing the appropriate terms (Free and Informed Consent Form / TALE, for children between 6 and 17 years old; and Term of Free and Informed Consent / ICF, for caregivers responsible for children up to 17 years of age and for patients aged 18 or over), according to Resolution 466, of December 12, 2012, of the National Health Council. service in which the patient is treated must be regularly and ethically registered in the registry, according to the norm of each institution.As patients using the MC-Ab appear, services will be registered through amendments and patients will be included, after signing the appropriate terms (TCLE / TALE). The study will remain open for the capture of new cases for 12 years and each patient will be followed for up to 10 years. The evaluated indicators will be collected at the frequency of each institution, based on the guidelines of the coordinating team. Attention will be paid so that there is at least one evaluation of each indicator before starting to use the MC-Ab.
Exclusion criteria
Exclusion criteria: Cases that complete the 10-year follow-up of the study; discontinue the use of MC-Ab for more than 6 months, for any reason; wish to leave the registry for any reason; evolve to death.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To perform a national registry for formal monitoring of patients using emicizumab as prophylaxis against bleeding in hemophilia A, including 100 patients over 10 years, following them for 2 to 10 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate indicators related to hemophilia A, such as bleeding rate, joint function, pain, physical activity, quality of life, hospitalizations, absenteeism and adherence, before and during the use of emicizumab. ;Assess the cost of treatment without and with emicizumab. ;Assess the safety of using the product. ;Evaluate the opinion of the interdisciplinary team regarding the therapy with the product and the product itself. ;Develop national recommendations and protocols for the use of emicizumab in hemophilia A.;Hold a national meeting to discuss the use of emicizumab. | — |
Countries
Brazil
Contacts
Public ContactJuliana Álvares-Teodoro
Universidade Federal de Minas Gerais
Outcome results
None listed