20 results
This study involves research and the objective of this study is to investigate the effect of esomeprzole on the single-dose pharmacokinetics (i.e., how a drug moves through the body) of telaprevir. And to obtain additional data regarding the safety…
The objectives are:- to provide access to telaprevir for subjects with chronic HCV genotype 1 infection who wererandomized to the control group in the C216 trial and who failed therapy for virologicreasons;- to evaluate efficacy, safety, and…
Secondary objectives are to evaluate the effect of intravenous FCM compared to pla¬cebo on:1. Evolution from baseline of cardiac function parameters as assessed by 2D Echo/Doppler cardiography 4, 12 and 24 weeks after start of study treatment.2.…
The primary objective is to demonstrate the superior efficacy of telaprevir in combination withPeg-IFN alfa-2a and RBV compared to standard treatment in subjects with chronic HCVgenotype 1 infection who failed prior treatment with Peg-IFN plus RBV.…
In this research we will investigate if i.v. iron therapy can become a method of blood saving therapy for orthopedic surgery and can replace erytropoietin.
The objective of this trial is to explore the efficacy, safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg q8h or 1125 mg q12h in combination with Peg IFN alfa2a (…
To measure the effect of intravenous ferric carboxymaltose treatment on exercise tolerance, microvascular perfusion and perioperative hemostasis in patients with mild iron deficiency anemia undergoing arterial vascular surgery.
To determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling subjects on a stable dose of pirfenidone or nintedanib and subjects not on other treatment for IPF.
To examine if intravenous administration of iron ismore efficacious than oral iron in improvement offitness scores, iron status and reduction of fatigue
To determine the effect size of three different doses of PRM-151 on reduction in bone marrow fibrosis by * 1 grade in intermediate-1, intermediate-2, and high risk subjects with PMF, post-PV MF, or post ET-MF who are anemic or thrombocytopenic and…
The purpose of this study will be to examine the effect of ferrous fumarate or ferinject in patients after a caesarean section with a hemoglobin level between 5.0. and 7.0 mmol/L.The primary outcome measure will be the hemoglobin level at 3 and 6…
To study the effects of FCM on exercise tolerance, haematinic parameters, quality of life, cardiac function, muscle function, bone and mineral parameters, microbiota, the immune system, the incidence of infections, allograft failure and mortality in…
Primary objective: To determine the reduction of number of patients who receive blood transfusion perioperatively in the group pre-treated with erythropoietin and iron supplement compared to the control patients.
To evaluate the effects of intravenous iron suppletion in iron deficient PAH patients.Amendment: to compare exercise capacity and isolated muscle strength in IPAH patients and healthy controls
Ferinject in patients with iron deficiency after primary RYGB. Which therapy is the most effective one to replace ironstorage?We also analyse the interval between initiation of therapy and adequate correction of iron deficiency.
Part 1:Prospective evaluation of serum ferritin levels after suppletion with ferrous fumarate, Losferron or Ferinject in patients with iron deficiency after primary RYGB. Which therapy is the most effective one to replace ironstorage?We also analyse…
Primary Objective(s)* To evaluate, relative to placebo, the effect of intravenous (IV) FCM on repeated heart failure (HF) hospitalisations and cardiovascular (CV) death.Secondary Objective(s)* To evaluate, relative to placebo, the effect of IV FCM…
The aim of this trial is to investigate which treatment option is superior in the treatment of anemia in patients undergoing surgery in terms of hemoglobin increase, postoperative morbidity, amount of bloodtransfusions needed, length of stay,…
To evaluate if hepcidin levels can predict response to iron therapy with either ferrous fumarate, ferric maltol, and intravenous iron in patients with IBD.
Asses whether, in patients with heart failure with preserved ejection fraction and iron deficiency, ferric carboxymaltose improves leftventricular diastolic function and skeletal muscle function by improving energy metabolism