15 results
This study aims to collect biochemical evidence for the pro-hemostatic capacity of DDAVP in patients with cirrhosis, in order to proceed towards a more rational clinical use of this drug.
Primary objectives:1) Describe the PD effects on plasma ACTH and serum cortisol upon 100 µg hCRH injection with or without a preceding injection of 10 µg dDAVP 2 hours earlier and study the PK-PD relationship (*Block B*). In particular, the outcome…
This proposal centers on hormone-behavior dynamics in paternal caregiving, with the goal of gaining a better understanding of the development of human paternal caregiving. There is limited information on the hormonal basis of caregiving patterns in…
The aim of this study is to investigate the influence of statin therapy on DDAVP mediated release of VWF and F VIII. We aim to investigate this by measuring F VIII and VWF levels by means of a prolonged DDAVP test prior and after 6 weeks of statin…
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…
The purpose of the study is to investigate to what extent FE 201836 is tolerated. It will also be investigated how quickly and to what extent FE 201836 is absorbed and eliminated from the body (this is called pharmacokinetics). Also the effect on…
The purpose of the study is to investigate to what extent FE 202217 is tolerated. It will also be investigated how quickly and to what extent FE 202217 is absorbed and eliminated from the body (this is called pharmacokinetics). Also the effect on…
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-…
1) To evaluate the safety and tolerability of MLT*s npMNAs2) To evaluate the pharmacokinetics of intradermal desmopressin administration via MLT*s npMNAs
To show a reduction in FVIII-concentrate consumption with perioperative desmopressin and FVIII concentrate combination treatment compared to FVIII concentrate monotherapy, without decreasing the effectivity of treatment.
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…
To investigate whether on demand dosing using population-based PK-models in VWD patients is reliable and feasible.
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…