Protocols

Newark Beth Israel Medical Center
Protocol List
November 2016
Protocol Name: My Life our Future: A Hemophilia Genotyping intiative/Data and Sample Research Repository available for hemophilia patients as well as known and potential carriers.

Sponsor: Biogen Idec Hemophilia/ATHN

Status: Open

Protocol Name: The American Thrombosis and Hemostasis Network (ATHN)/Patient Authorization/Opt in to Participate in ATHN dataset

Sponsor: The American Thrombosis and Hemostasis Network

Status: Open

Protocol Name: Community Counts-Authorization for Use of Information and Blood Samples for the CDC Public Health Surveillance for Bleeding Disorders-Registry for Bleeding Disorders Surveillance.

Sponsor: Center for Disease Control and Prevention/ American Thrombosis and Hermostasis Network.

Status: Open

Protocol Name: BAX 855 PUP Study, a Phase 3, prospective, multi-center, open label study to investigate safety, immunogenicity and hemostatic efficacy of PEGylated factor VIII (BAX 855) in previously untreated patients (PUPs) <6 years with severe hemophilia A (FVIII<1%).

Sponsor: Baxalta US Inc.; Baxalta Innovations GmbH

Status: Open

Protocol Name: GBI1406, A multicenter Phase 2 Open-Label, Single Arm, Prospective, Interventional Study of Plasma-Derived Factor VIII/VWF (Alphanate®) in Immune Tolerance Induction therapy in Subjects with Congenital Hemophilia A.

Sponsor: Grifols

Status: Open

Protocol Name: Dream Evolving Real World use of Standard and EHL Products in Moderate and Severe Hemophilia Patients.

Sponsor: Hemophilia of Georgia

Status: Open

Protocol Name: Kids-DOTT Trial Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children.

Sponsor: All Children's Hospital John Hopkins Medicine (St. Petersburg, FL) All Children's Hospital Foundation

Protocol Name: A Phase 2b, Multicenter, Open-Label Study to investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects with Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

Sponsor: Gilead Sciences, Inc.

Status: Closed to enrollment

Protocol Name: Hemophilia Inhibitor Research Study-Phase III

Sponsor: Center for Disease Control and Prevention

Status: Closed to enrollment

Protocol Name: Single dose open-label PK/PD, safety and tolerability study of dabigatran etexilate mesilate given at the end of standard anticoagulant therapy in children aged 1 year to less than 2 years.

Sponsor: Boehringer Ingeelheim Pharmaceuticals, Inc.

Status: Closed to enrollment

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