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Efficacy and Safety of Concizumab prophylaxis in patients withhaemophilia A or B without inhibitors
To establish the effect and investigate safety of daily subcutaneous treatment with concizumab prophylaxis when given to adult and adolescent haemophilia patients without inhibitors.
There will be approximate 28 in person visits with blood drawn at 27of these.
Body weight >25 kg at screening
Congenital severe haemophilia A (FVIII < 1%) or moderate/severe B (FIX ≤ 2%)
Documented treatment with coagulation factor containing product in the last 24 weeks
Participation in any clinical trial of an approved or non-approved investigational product within 5 half-lives or 30 days from screening
Known or suspected hypersensitivity to monoclonal antibodies
History of thromboembolic disease
inhibitors ≥0.6 BU in the last 5 years
A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients
Study of the safety of unlicensed cord blood units for stem cell transplant of children and adults.
You are receiving unlicensed CB products from other CB banks
Study of Angelica gigas dietary supplements (Cogni.Q) and potential effects on human immune cells
This human study will test the impact of dietary supplement vegicaps containing Korean Angelica root extract on 2 types of human immune cells: neutrophils that kill bacteria and other germs and natural killer (NK) cells that kill virus-infected cells and cancers. We had done an earlier study with Korean Angelica supplement and discovered even a single dose of it increased blood neutrophils and NK cells within 24 h. In the new study, Korean Angelica capsules (Cogni.Q) will be compared head-to-head with dummy (placebo) capsules. This is to make sure the immune boosting actions are really from the Korean Angelica supplement.Approximately 40 men will take part in this research study at Hershey Medical Center.
Subjects weighing between 110 to 240 pounds; their body mass index (BMI) should be in the range of 19=< BMI >=30
Subjects having normal hepatic, renal function as assessed by history, physical and clinical chemistry analysis (CMP eGFR).
Subjects with normal blood pressure (systolic below 120 mm Hg and diastolic below 80 mm Hg)
Subjects taking any kind of prescription medications regularly or within 10 days of the study will be excluded.
Subjects taking dietary or herbal supplements that contain AGN (e.g. Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin) within 10 days of the study.
ATHN 10: Leveraging the ATHNdataset to Document the State of RareCoagulation Disorders in the United States
This is a multi-center project in which the American Thrombosis & Hemostasis Network (ATHN) will offer free genotyping to individuals with Rare Coagulation Disorders (RCD).
One tube of blood will be collected during a routine clinic visit.
Must currently receive or have received care at and ATHN affiliated HTC
Subject must have opted into the ATHNdataset
Open-label safety study in adults and adolescents with haemophilia A with and without FVIII inhibitors switching directly from emicizumab prophylaxis to NNC0365-3769 (Mim8) prophylaxis
A research study looking at how safe it is to switch from emicizumab (Hemlibra) to Mim8 in people with haemophilia A.
The study will last for about 6-12 months. Subjects will have between 6 and 27 Mim8 injections depending on dosing frequency. There will be 9 clinic visits. Blood will be drawn at all 9 of the visits.
$75 per visit to cover travel expenses
Treated with emicizumab QW, Q2W, or Q4W according to the label for at least 8 weeks prior to screening.
Age 12 years or above at the time of signing the informed consent.
Patients choosing to discontinue emicizumab treatment and switch to Mim8 QW, Q2W, or QM treatment for 26 weeks from start of treatment.
Willingness and ability to comply with scheduled visits and study procedures, including the completion of an electronic diary and patient-reported outcomes (PRO) questionnaires.
Previous or current thromboembolic disease or events or risk of thromboembolic disease, as evaluated by investigator or risk of thromboembolic disease, as evaluated by investigator.
Receipt of FVIII gene therapy at any time.
Ongoing or planned immune tolerance induction therapy.
Minor or major surgery planned to take place after screening and during the 26-week treatment period.