Search results for "Extension study"
showing 6 items of 6 documents
Open-label extension study of the RNAi therapeutic ALN-VSP02 in cancer patients responding to therapy.
2012
3062 Background: ALN-VSP02 is an RNA interference (RNAi) therapeutic comprised of lipid nanoparticle-formulated small interfering RNAs targeting vascular endothelial growth factor (VEGF)-A and kinesin spindle protein (KSP). In a phase 1 trial, ALN-VSP02 administered as an iv infusion q2 wks was well-tolerated and showed evidence of anti-VEGF pharmacology and antitumor activity. Methods: Patients treated on the phase I trial with stable disease (SD) or better after 4 months (8 doses) were eligible to continue on an extension study until disease progression. Main objectives included continued evaluation of safety/tolerability and assessment of disease response. Results: Seven of 37 patients …
Reveglucosidase alfa (BMN 701), a GILT-tagged recombinant human acid alpha glucosidase (rhGAA), evaluation in late-onset Pompe disease: Preliminary c…
2015
A Phase III Extension Study of Aldurazyme®(Laronidase) in Mucopolysaccharidosis I
2007
Correction: Corrigendum: Long-term, open-labeled extension study of idursulfase in the treatment of Hunter syndrome
2013
CORRIGENDUM: Long-term, open-labeled extension study of idursulfase in the treatment of Hunter syndrome
Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one‐year extension study
2021
Background: Ligelizumab, a next-generation, humanized anti-immunoglobulin E (IgE) monoclonal antibody is in development as a treatment for patients with chronic spontaneous urticaria, whose symptoms are inadequately controlled with standard-of-care therapy. Objective: To evaluate the long-term safety and re-treatment efficacy of ligelizumab 240 mg in patients who completed the core study and extension study. Methods: This open-label, single-arm, long-term Phase 2b extension study was designed to assess patients who were previously administered various doses of ligelizumab, omalizumab or placebo in the Phase 2b, dose-finding core study and who presented with active disease after Week 32. In …