Clinical Trials Articles
A clinical trial comparing the protective efficacy in older adults of a quadrivalent recombinant influenza vaccine with a standard-dose, egg-grown quadrivalent inactivated influenza vaccine during the A/H3N2-predominant 2014-2015 influenza season showed RIV4 provided better protection against confirmed influenza-like illness among older adults.
Results of a Phase II clinical trial ofPfizer’s preventive vaccine againstClostridium difficile (C. diff) showed the vaccine was safe and stimulated a C. diff targeted immune response.
A PhaseI/II study of nine patients with hemophilia B who underwent Spark Therapeutics’ SPK-9001 gene therapy are promising, despite two adverse autoimmune reactions.
A Phase I/II study indicates that haplo identical hematopoietic stem cell transplantation (haplo-HSCT), after depletion of α/β T cells and B cells followed by adoptive infusion of donorBPX-501 cells, is an effective alternative for children with primary immunodeficiency disease (PI) in need of an urgent allograft or lacking a suitable human leukocyte antigen (HLA)-matched donor.
Results from the Phase III PROLONG9FP ongoing extension clinical development program evaluating the long-term efficacy and safety of IDELVION (coagulation factor IX [recombinant], albumin fusion protein) showed that extended prophylaxis treatment regimens effectively prevented bleeds while also reducing overall IDELVION consumption.
Baxalta has begun a Phase I, first-inhuman clinical trial of BAX 826, a recombinant factor VIII (rFVIII) treatment for hemophilia A that uses proprietary polysialic acid (PSA) technology to extend its circulating half-life.
President Obama signed a bill into law that will compensate patients for participating in clinical studies of rare diseases.
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).
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).
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.
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 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.
