7 results
The primary objective is to evaluate the antiviral efficacy of TMC435 in combination with PegIFN*-2a and RBV.In addition to this, the study provides access to TMC435 treatment in combination with PegIFN/RBV to (1) subjects whoparticipated in the…
The overall objectives of the iSPOT-D trial are to use standardised genetic-brain-cognitionprotocols to:1. Identify markers of MDD as a diagnostic group and its subtypes2. Identify markers which change with acute (8 weeks) drug treatment in MDD3.…
Co-primary (tested in parallel for non-inferiority):- To compare daprodustat to rhEPO for CV safety (non-inferiority)- To compare daprodustat to rhEPO for Hgb efficacy(non-inferiority)
The primary objective of the study are to: 1) Determine the safety and tolerability of G1T48 alone (Parts 1 and 2) or in combination with palbociclib (Part 3), 2) Determine the MTD and RP2D of G1T48 alone (Parts 1 and 2) or in combination with…
Co-primary (tested in parallel for non-inferiority):-To compare daprodustat to darbepoetin alfa for CV safety (non-inferiority)-To compare daprodustat to darbepoetin alfa for Hgb efficacy(non-inferiority)
Primary objectives: - Describe the safety of daprodustat, overall (all ages) and in each age group.Secondary objectives:- Describe changes in other parameters relevant to safety, overall and in each age group.- Describe the effect of daprodustat on…
Phase 1Primary ObjectivesTo assess the safety and tolerability of orally administered CLN-081 monotherapy.To define the maximum tolerated dose (MTD) of orally administered CLN-081 monotherapy.Secondary ObjectivesTo assess the anti-tumor activity.To…