Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America
Blood Coagulation DisordersHemophilia AThe aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
AdenovirusAnesthesia57 moreUnderstudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).
Kogenate FS Regulatory Post-Marketing Surveillance
Hemophilia ATo obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications. The observation period for each patient is up to 6 months.
Post Marketing Observational Study of Reformulated BeneFIX
Hemophilia BThe primary objective of this observational study is to collect safety data on reformulated BeneFIX as prescribed in routine clinical practice conditions in France. The secondary objectives are to collect data on the clinical course of individuals treated with reformulated BeneFIX and on the ease of reformulated BeneFIX.
2-cohort Study of Adult Patients With Severe Hemophilia A in Greece
Hemophilia AThis study is a prospective, single center, observational, 2-cohort study of adult patients with severe Hemophilia A. There is no randomization procedure and all patients will be treated as per usual clinical practice. Patients will be followed up for 18 months after enrolment.
A Long-term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective...
Congenital Bleeding DisorderHaemophilia A With Inhibitors1 moreThis study is conducted in the United States of America (USA). The aim of this study is to assess the long-term (5+ years) postoperative functional outcomes of elective orthopaedic surgery (EOS) patients from previously reported studies F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391) and furthermore to assess the impact of EOS on psychosocial outcomes, frequency of bleeding episodes and durability of joint surgery.
Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated...
Hemophilia AThe purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to severe hemophilia A.
Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving...
Hemophilia ACongenitalThe primary objective of this study is to investigate weekly prophylaxis dosing regimens used in standard clinical practice. In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose & dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data (if performed), KOVALTRY consumption, as well as safety data.
Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)
Hemophilia AThis study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when administered as 2 different dose presentations. The first is the current product vials with prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.
Hepatitis Delta Infections in Hemophiliacs
Blood DiseaseHepatitis4 moreTo elucidate the role of hepatitis delta virus (HDV) in the development of chronic liver disease in patients with hemophilia.