The oral presentation reviewed interim analyses
from two ongoing double-blind, placebo-controlled Phase 2a studies of 731 in HBV subjects evaluating the potential benefit of combination with standard of care Nuc therapy.
The interim analyses
for the VX-659 and VX-445 triple combination regimens will enable Vertex to evaluate comparable data from both Phase 3 triple combination programs and determine the best regimen to submit for potential regulatory approval.
The size of the DMC also varies--there are usually at least three members but there can be many more DMC members for large studies or for studies that require detailed monitoring and interim analyses
The two interim analyses
were done to provide information to support the design and execution of Aastrom's Phase 3 CLI program.
using these improved stains show that placental malaria is significantly associated with mother-to-child HIV transmission, and that the presence of malaria increases the mother's HIV viral load.
The next interim analysis for the OS primary endpoint is scheduled for 2Q19 with additional interim analyses
every six months.
7 October 2010 - US medical devices maker Baxter International Inc (NYSE:BAX) said yesterday that interim analyses
of a Phase III study showed that 28 out of 29 patients with primary immune deficiency (PID), who received the company's HyQ, were able to infuse IG under the skin at infusion volumes, intervals and rates equivalent to previous intravenous administration of IG.
Prior to the second interim analysis and with the agreement of the IDMC, the Company had submitted a protocol amendment to the FDA, establishing safety reviews as the basis for the second interim analysis and for subsequent interim analyses
. The PAC203 study is evaluating the safety and efficacy of three dosing schedules over 24 weeks in patients with myelofibrosis previously treated with ruxolitinib.
The DMC's interim analyses
will evaluate safety, efficacy and futility to determine if there is significant evidence of clinical benefit.
There will be interim analyses
at the 50% and 75% point of the trial as measured by the number of patients treated.