10 results
Primary ObjectiveThe primary objective is to compare the annualized rates of bleeding episodes (ABR)between subjects receiving a prophylactic regimen of BAX 855 with an on-demandtreatment regimen.Secondary ObjectivesThe key secondary objective is to…
7.2 Primary ObjectiveThe primary objective is to assess the incidence of FVIII inhibitory antibodies(>=0.6 Bethesda units [BU] using the Nijmegen modification of the Bethesda assay).7.3 Secondary Objectives1. To evaluate the PK parameters of…
To determine the therapeutic effect of vardenafil 10 mg taken twice daily (BID) on Overactive Bladder by means of urodynamic measurements (filling cystometry and pressure flow investigations).
PrimaryPhase 1-To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory cHL, DLBCL or PTCL, and to confirm the recommended Phase 2 dose (RP2D).Phase 2- Cohort A1 (anti-…
Phase1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and…
In men without erectile problems, night time erections occur during the REM-sleep. For this study we will compare the current diagnostic test, the Rigiscan, with the data from de TRIP-Patch during the night. To validate discriminating sensor-…
Primary:• Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA.• Part B: To evaluate the efficacy of the selected dose in adults with wAIHA.Secondary:• Part A (Cohorts 2 and 3 only)-To…
DOSE EXPLORATION:Primary:To determine the safety and tolerability of GSK2857916 in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each sub-study combination treatment.Secondary:…
Primary objective-To compare rate of Minimal Residual Disease (MRD) negativity by NGS between Isa-KRd and KRd in post ASCT consolidation treatment.Key secondary objectives- Rate of MRD negativity after induction by NGS- To compare progression-free…
Primary objective:To evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute…