There was a notable difference in the regimens between the studies: in the Phase 2 study, VB-111 was administered first as a single agent therapy with bevacizumab added to VB-111 upon further progression; in contrast, the GLOBE Phase 3 study regimen included co-administration of VB-111 and bevacizumab from the start of study therapy
without any VB-111 monotherapy priming period.
Eight subjects have been randomised to receive the study therapy
, which is administered in a series of eight injections along with standard care.
It may be supposed that responding to it involves a series of variables to consider, in addition to the time, i.e., the follow-up period, from when the study therapy
is administered until a change occurs in the clinical course of the disease.
A total of four serious adverse events were thought to be related to study therapy
and all occurred in the SOF/LDV/RBV arms.
"The incidence of the adverse events declined markedly after 2-4 weeks of study therapy
Our study therapy
of active Crohn's disease with Boswellia serrata extract H15 [Z.
Compliance with study therapy
and tolerability were comparable in the 3 treatment groups.)
Women who were clinically cured were randomized to either placebo or the study therapy
: a 6-month course of once-weekly 150-mg oral fluconazole.
Fourteen patients were excluded from the final analysis for the following reasons: absence of photographic confirmation of CMV retinitis at study entry (5); noncompliance with study therapy
(4); absence of efficacy data reported after randomization (3); presence of a ganciclovir implant in one eye (1); and no receipt of any doses of study drug (1).
HCFA is to study therapy
services and report to Congress on establishment of an alternative payment policy.
Four responders, all of whom have been on study therapy
for over a year, currently remain on treatment.