BCDI is committed to provide the most cutting edge treatment opportunities for Bleeding disorder patients. To that end, BCDI participates in a variety of clinical trials for bleeding disorder patients.
What is a clinical trial? /filesimages/What is a Clinical Trial (4).pdf
What is informed consent? /filesimages/What is informed consent (13).pdf
The following clinical trials are currently available at BCDI. Click on the links below to learn more information.
Hemophilia A and B
•Baxalta 261203 - Phase 3 prospective study of the safety and efficacy of Prophylactic BAX855 in previously un-treated patients with severe hemophilia A <6 years old
•Baxalta 241502 - study to evaluate the efficacy and safety of BAX 802 in males with congenital hemophilia A (CHA) with inhibitors who are undergoing major or minor elective surgical, dental, or other invasive procedures.
•OPKO Biologics CP-5-001 - Phase 1 study - one injection of a long acting recombinant factor VIIA in adult men with Hemophilia A or B - inhibitor or no inhibitor.
• Novo Nordisk - Guardian 5 (3553) - a non-interventional study of Novo Eight during long-term treatment of sever and moderately severe hemophilia A patient.
•Novo Nordisk - Alliavate (4213) - A study of a single Sub-Cutaneous injection of N8GP and placebo with PK evaluation for patient with severe hemophilia A
Von Willebrand Disease
• This study is to improve the investigators ability to diagnose von Willebrand Disease (VWD), a common inherited bleeding disorder. This study will look at a new screening blood test used to determine if a person has VWD.
• Shire 071102 - A study of recombinant von Willebrand factor with or without Advate to treat and control bleeding episodes, elective and emergency surgeries in children diagnosed with severe von Willebrand disease.
• Pfizer B0661037 - Study Of Apixaban Versus Standard Of Care In Pediatric Patients Requiring Anticoagulation For The Treatment Of A Venous Thromboembolic Event
Data Collection Studies gather clinical data on bleeding disorder patients and the data helps physicians develop best practices for the treatment of bleeding disorder patients.
Current Data collection studies available at BCDI. Click the links below to learn more information.
• ATHN-2 Longitudinal observational study of previously treated hemophilia patients switching factor product.
• 241302 - Post-Marketing; non-interventional safety evaluation of obizur in the treatment of bleeding epidodes for patients with acquired hemophilia A.
General Bleeding/Clotting Disorders
•ATHNDATA SET: ATHN's safe and secure national patient health data resource - the ATHNdataset - has grown to include over 23,646 patients who have chosen to "opt-in" by signing a patient authorization at their Hemophilia Treatment Center (HTC).
•CDC REGISTRY- CDC Public Health Surveillance for bleeding Disorders - Registry for bleeding disorders surveillance.
•SCNIR: Severe Chronic neutropenia International Registry an organization dedicated to improving understanding and treatment for diseases causing severe chronic neutropenia.
• Cost of Illness and Impact of von Willebrand Disease: A Pilot study
•Outcomes of Regional Consensus Treatment Guidelines for Management of Surgery, Invasive Procedures and Control of Hemorrhages in Patients with Bleeding Disorders; and Management of Thrombosis and Thromboprophylaxis in patients with Thrombophilia.