Extended Half-Life (EHL) Clotting Factor for Improving the Musculoskeletal Health of Patients With Hemophilia
Keywords
Abstract
Dates
Last Verified: | 12/31/2019 |
First Submitted: | 04/10/2019 |
Estimated Enrollment Submitted: | 04/11/2019 |
First Posted: | 04/15/2019 |
Last Update Submitted: | 01/22/2020 |
Last Update Posted: | 01/26/2020 |
Actual Study Start Date: | 02/01/2020 |
Estimated Primary Completion Date: | 11/09/2020 |
Estimated Study Completion Date: | 12/14/2020 |
Condition or disease
Intervention/treatment
Other: EHL clotting factor
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
EHL clotting factor This study shall not implement any intervention that might alter the normal development of the daily life activities of hemophilia patients included in the study. They will continue with the prophylactic regimen prescribed by their hematologist. Patients will also be asked to continue to develop their physical, work, entertainment and leisure activities in the same way as at baseline. | Other: EHL clotting factor This study shall not implement any intervention that might alter the normal development of the daily life activities of hemophilia patients included in the study. They will continue with the prophylactic regimen prescribed by their hematologist. Patients will also be asked to continue to develop their physical, work, entertainment and leisure activities in the same way as at baseline. |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | Male |
Sampling method | Probability Sample |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - Patients diagnosed with hemophilia A - Patients over 18 years - Patients under prophylactic treatment with rFVIIIFc concentrates. Exclusion Criteria: - Patients with neurological or cognitive disorders preventing the understanding of the various measuring instruments - Patients who are scheduled for major orthopedic surgery (total arthroplasty) - Not signed the Informed Consent Document |
Outcome
Primary Outcome Measures
1. Change from baseline bleeding frequency after one year of follow-up [Screening visit, at six months and after one year of follow-up]
Secondary Outcome Measures
1. Change from baseline dosage of factor VIII with EHL products after one year of follow-up [Screening visit, at six months and after one year of follow-up]
2. Change from baseline joint pain after one year of follow-up [Screening visit, at six months and after one year of follow-up]
3. Change from baseline joint pain after one year of follow-up: Pressure algometer [Screening visit, at six months and after one year of follow-up]
4. Change from baseline kinesiophobia after one year of follow-up [Screening visit, at six months and after one year of follow-up]
5. Change from baseline joint status after one year of follow-up [Screening visit, at six months and after one year of follow-up]
6. Change from baseline lower limb functionality after one year of follow-up [Screening visit, at six months and after one year of follow-up]
7. Change from baseline muscle strength after one year of follow-up [Screening visit, at six months and after one year of follow-up]
8. Change from baseline adherence to prophylactic treatment after one year of follow-up [Screening visit, at six months and after one year of follow-up]