Rare Clinical Trial Compensation Legislation Is Signed Into Law
President Obama signed a bill into law that will compensate patients for participating in clinical studies of rare diseases.
The Perfect Storm for Patient-Focused Clinical Trials
Improving clinical trial enrollment numbers is a key challenge to advancing research, but a host of solutions suggests a new era of patient engagement and patient-focused clinical trials.
ADMA Biologics’ IVIG Product (RI-002) Receives Positive Phase III Results
ADMA Biologics has received positive results on the primary and secondary endpoint evaluations from the Phase III trial for its intravenous immune globulin (IVIG) product RI-002 to treat primary immunodeficiency disease(PI).
Higher Dosages of 25% Albumin Associated with Lower Incidence of Cerebral Ischemia and Infarction in Pilot ALISAH Study
The “Albumin in Subarachnoid Hemorrhage” (ALISAH) pilot clinical trial, conducted at the Baylor College of Medicine in Houston, assessed the neuroprotective effects of varying dosages of 25% human albumin. Vasospasm, delayed cerebral ischemia (DCI) and cerebral infarction were evaluated in 20 patients who received seven consecutive daily infusions of 0.625 g/kg (Tier 1), 20 who received 1.25 g/kg (Tier 2), and seven who received 1.875 g/kg (Tier 3).
4-Factor Prothrombin Complex Concentrate Superior to 3-Factor Version for Reversal of Coumarin Anticoagulation in Rat Model
In an established preclinical bleeding model, reversal of coumarin anticoagulation with Kcentra, a four-factor prothrombin complex concentrate (4F-PCC), was shown to be superior to three-factor prothrombin complex concentrates(3F-PCCs), according to findings reported by CSL Behring investigators.
rFVIII Treatment for Hemophilia A Receives Positive Results
Baxter’s Phase III clinical trial of BAX855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE (Antihemophilic Factor[Recombinant]), has met its primary endpoint in reducing annualized bleeding rates (ABR) in the prophylaxis arm compared with the on-demand arm.
CSL Enrolls First Patient in Study of rVIII-SingleChain
CSL Behring has enrolled its first patient in the pivotal pediatric PhaseIII study to evaluate the efficacy, safety and pharmacokinetics of its novel investigational recombinant factor VIII single chain (rVIII-SingleChain) for the treatment of previously treated children (up to 11 years) with severe hemophilia A.
Phase III Trial for Long-Acting Factor VIII Shows Positive Results
Positive results have been shown with the completion of pathfinder2 for hemophilia A patients 12 years and older.
