Clinical Trials Articles
Observational studies suggest immune globulin (IG) treatment may reduce the frequency of acute exacerbations of chronic obstructive pulmonary disease (AECOPD).
A large multicenter clinical trial has found intravenous immune globulin (IVIG) plus glucocorticoids may be better than IVIG alone for treating multisystem inflammatory syndrome in children (MIS-C) caused by COVID-19.
The CoVIg-19 Plasma Alliance now includes 11 plasma companies, and now also includes global organizations from outside the plasma industry.
Results from Genentech’s Phase III PEMPHIX study evaluating the efficacy and safety of Rituxan (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV) showed the study met the primary endpoint at week 52 and demonstrated Rituxan is superior to MMF.
In pharmacokinetic studies, a recombinant fusion protein genetically linking human coagulation factor IX with human albumin (rIX-FP) (IDELVION, CSL Behring) has been shown to have an approximately five-fold longer half-life compared with standard recombinant factor IX products.
Following a review by the Independent Data Monitoring Committee (IDMC) of preliminary results from the Phase II portion of an ongoing Phase II/III trial evaluating Kevzara (sarilumab), the trial was amended so only critical patients continue to be enrolled to receive Kevzara 400 mg or placebo.
Octapharma USA is supporting a new investigator-initiated clinical trial led by George Sakoulas, MD, of Sharp Memorial Hospital in San Diego, Calif., focused on treating the most critical coronavirus patients who are experiencing respiratory failure who become ventilator dependent.
Novartis has initiated a Phase III clinical trial to examine the efficacy of utilizing canakinumab (Ilaris), an interleukin (IL)-1β blocker, to treat a type of severe immune overreaction called cytokine release syndrome (CRS) in people with COVID-19 pneumonia.
Inato, a marketplace that helps biopharmaceutical companies increase the pool of available patients engaged in clinical trials, has unveiled its anticovid platform, a comprehensive, central repository for all existing clinical trials for SARS-CoV 2 (the virus that causes COVID-19).
Efgartigimod, an investigational human IgG1 Fc fragment, induced a rapid reduction in total IgG levels and clinically relevant increases in platelet counts in patients with primary immune thrombocytopenia (ITP), according to findings from a Phase II, placebo-controlled multinational study.
A study in previously untreated patients (PUPs) with severe hemophilia A found replacement therapy with a fourth-generation recombinant factor VIII (FVIII) product was associated with an incidence of high-titer inhibitors similar to the rate seen in a landmark trial evaluating plasma-derived FVIII products.
A Phase III study has found a trivalent hepatitis B virus (HBV) vaccine demonstrated superiority in adults 45 years and older and noninferior in adults older than 18 years compared with a monovalent vaccine.
