Comparison of Two Types of Ankle Braces in the Management of Ankle Pain in Hemophilia
Arthropathy Due to Bleeding From HemophiliaThis project proposes to examine the difference in effectiveness of fracture boots and carbon fiber braces in the management of gait abnormalities and pain relief due to ankle pain from arthritis due to ankle bleeds. Fracture boots are "walking casts" that you can put on and take off. They prevent the ankle from moving and have a curved sole to mimic normal walking. They can help relieve pain of ankle arthritis from ankle bleeds by stopping ankle motion and absorbing some of the body's own weight while walking. Carbon fiber braces use newer technology resulting in lighter and smaller braces. They are designed to assist with helping clear the toe and straighten the knee while walking. Gait analysis wearing both the fracture boot and carbon fiber brace will be performed by walking on a mat equipped with pressure sensors and will examine the effect of the fracture boot and the carbon fiber brace on how you walk. These tests will be compared to walking on the mat without either brace. The sensors on the mat will measure different aspects of gait such as step length and foot position. You will be asked questions about how much ankle pain you have using no brace compared to each brace. People with hemophilia A or B and ankle pain from bleeds will be asked to participate. They will be approached during routine clinic visits and will also be contacted by telephone. Levels of pain will be measured before, during and after each trial using standardized visual analog and ordinal pain scales. Measurements from the gait mat and levels of pain relief will be used to determine effectiveness of each type of support. Statisticians will be used to analyze results of the gait mat and pain scale measurements.
International PMS Study - KOGENATE Bayer
Hemophilia ATo evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand. To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.
Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion...
Hemophilia AThe objective of this international post-marketing surveillance study is to collect data on the efficacy and safety of continuous infusion with KOGENATE Bayer in surgery.
ADVATE Post Authorization Safety Surveillance
Hemophilia AThe primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.
Hepatitis C in Clinically Discordant Hemophilic Siblings
Blood DiseaseHemophilia A3 moreTo define the natural history, immunologic, and genetic factors that influence the clinical outcome of hepatitis C in a cohort of hemophilic siblings.
Safety, Efficacy Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia...
Hemophilia AThis is a multi-center, open-label, single-arm trial to evaluate the efficacy and safety of Recombinant Coagulation Factor VIII in patients with hemophilia A . Recombinant Coagulation Factor VIII is prophylactic administrated 25 - 35 IU/kg once every other day or three times per week which should be continuous for 24 weeks.
A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia...
Haemophilia BAlprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic treatment of haemophilia B.
Long-Term Safety, Tolerability, and Efficacy of DTX101 (AAVrh10FIX) in Adults With Moderate/Severe...
Hemophilia BA long-term follow-up study to evaluate the safety, tolerability, and efficacy of DTX101 in adult males with moderate/severe to severe hemophilia B.
Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®
Hemophilia AHemophilia1 moreThe purpose of this study is to describe the pharmacokinetic profile of patients with hemophilia A in prophylaxis in Spain using myPKFit®
Post-Marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe...
Factor VIII DeficiencyCongenital6 moreThis study aims to observe the safety and efficacy of the Xyntha Solofuse prefilled syringe in the setting of routine practice. The primary objective is to detect medically significant events (factor VIII inhibitor). The secondary objective is to observe the overall efficacy and safety of the Xyntha Solofuse prefilled syringe including serious adverse events. In this open-label, non-comparative, observational, non-interventional, retrospective and multi-center study, post-marketing surveillance data will be collected retrospectively for up to 6 months from the initial administration day of the Xyntha Solofuse prefilled syringe injected into patients who have been administered the Xyntha Solofuse prefilled syringe. As specified in the product approval issued by the Ministry of Food and Drug Safety, the study will be conducted for 4 years from the approval date. At least 600 study subjects will be enrolled in this study to meet the MFDS requirements. Although 600 is the assigned number of study subjects, the number of cases will be adjusted considering the actual number of enrolled subjects after the study start day.