31 results
Primary objective: to compare the effect two immunosupressive therapy regimens on GFR estimated by iohexol clearance at week 52 post kidney transplantationSecundary objective: to compare the safety and efficacy profiles of the two immunosupressive…
PRIMARY OBJECTIVES Part I - To evaluate the efficacy (as measured by PFS) of GDC-0941 340 mg +carboplatin * paclitaxel (Arm A) versus carboplatin * paclitaxel (Arm B) in all patients with squamous NSCLC -To evaluate the efficacy (as measured by PFS…
To decrease the cumulative incidence of (hematological) relapse
Primary Objective: The primary objective is to determine whether the administration of Gelofusine will reduce the kidney uptake of 111In-labeled exendin in humans by enhancing the excretion of 111In-labeled exendin. These highly relevant data can…
The primary objectives of this study is:* To determine the safety and tolerability of rhHNS via ascending doses administered via a surgically implanted intrathecal drug device (IDDD) once monthly for 6 months, in patientswith MPS IIIA.The secondary…
The primary objective is to evaluate the effect of a once-a-weekprophylaxis regimen with BAY 79-4980 on the protection from all bleeds compared to a three times-per-week prophylaxis regimen with rFVIII-FSWFI.
To assess the safety and tolerability of escalating single IV doses of NI-0801.To determine the pharmacokinetics and pharmacodynamics parameters of escalating single IV doses of NI-0801.
The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure. Secondary objective is the quality of life and effect on intestinal permeability.
The objective of this study is to assess the efficacy and safety of adalimumab in combination with a topical treatment for the treatment of patients with moderate to severe chronic plaque psoriasis.
To investigate how quickly and to what extent diclofenac is absorbed and eliminated from the body (this is called pharmacokinetics) when it is administrated by using a HP 5000 transdermal patch. Furthermore, the pharmacokinetics of HP-5000…
To assess safety, tolerability and pharmacokinetics of a single subcutaneous administration of HPV-NIRD1.
The primary objective is to correlate ex vivo 111In-exendin tracer accumulation in the pancreas of patients undergoing pancreatectomy for pancreatic cancer or chronic pancreatitis to establish the relation between tracer uptake and beta cell mass in…
The primary objectives of this study are:• To determine whether ART-123, when administered to subjects with infection complicated by at least one organ dysfunction and coagulopathy, can reduce mortality.• To determine the safety of ART-123 in this…
Main objectives: safety and efficacy of BAY94-9027 for prophylaxis and treatment of bleeding in PTP with hemophilia ASecondary objective: PK
The purpose of this study is to investigate how quickly and to what extent different doses of EUapproved Tysabri® are absorbed and eliminated from the body (this is called pharmacokinetics) and how the body responds to different doses of Tysabri (…
1. To evaluate the safety and tolerability of ascending multiple oral doses of HTL18318 in healthy adult male and female subjects.2. To evaluate the pharmacokinetics of ascending multiple oral doses of HTL18318 in healthy adult male and female…
Main objective of the trial is to determine the effect of individualizing the immunosuppressive therapy based on baseline immune-risk stratification according to 2 new biomarkers (d-sp ELISPOT IFN-γ and donor/recipient HLA Eplet Mismatch), in a…
The main purpose of this trial is to find out if an investigational drug called setmelanotide (RM-493), which mimics MSH, can help control body weight. The efficacy of setmelanotide will be compared to the efficacy of a placebo during 4 to 8 weeks.
Primary Objective: Compare the uptake of 68Ga-NODAGA-exendin-4 in the liver between T1D patients with functional islet grafts (C-peptide > 0.8 nmol/L after mixed meal stimulation test and relevant laboratory parameters as HbA1C and exogenous…
Objective(s)* To investigate the pharmacokinetic behaviour of a single dose of MMF;o Plasma concentrationso Cellular concentrationso Relationship between plasma and cellular concentrations* To investigate the pharmacodynamic effects of a single dose…