19 results
The primary objective of this study is to assess whether *omics technologies are sensitive and specific enough to be used as a chemical risk assessment tool for humans. More specifically the study will demonstrate if there are different and / or…
The objective of this trial is to investigate whether Eltrombopag added to standard immunosuppressive treatment increases the rate of early (at three months) complete response and blood counts and can be use as front-line therapy for SAA treatment.
To provide continuing treatment with eltrombopag for subjects who are currently participating in a GSK sponsored investigational study of eltrombopag (parent study) and to collect long term safety data.
Part 1 (open-label, 8 week): safety and tolerability of eltrombopag, optimal dose escalation scheme for use in Part 2, PK.Part 2: Primary: the reduction in the number of clinically relevant thrombocytopenic events (*Grade 3 hemorrhagic adverse…
Objective: To investigate whether acetaminophen is effective in treating self-reported sleep problems.
Primary objective: to study the pharmacokinetics and pharmacodynamics of paracetamol intravenously in preterm infants with a gestational age of less than 32 weeks:Secondary objective(s): to study the safety and dose-effect relationship of…
1)to compare the analgesic efficacy of intravenous versus rectal paracetamol as assessed by VAS scores, PCA morphine consumption.2)To assess the pharmacokinetic profile of intravenous and rectal paracetamol by intravenous plasma paracetamol and…
Primary objective: - To study the pharmacokinetics of acetaminophen and metabolites in morbidly obese patients and compare with normal weight patients. Secondary objectives: - To compare the pharmacokinetics of acetaminophen and metabolites in…
Primary objective: To assess the effect of early treatment with paracetamol in a daily dose of 6 g for three consecutive days in patients with acute stroke and a body temperature of 36.5°C or above on the occurrence of a favorable functional outcome…
Core StudyPrimary objective• To compare the efficacy of E5501 (in addition to standard of care) to eltrombopag (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic thrombocytopenic…
Primary research question:- Does treatment with drugs modulating vasoconstriction, i.e. COX-inhibitors (acetaminophen) or calcium-antagonists (nimodipine), improve electrographic postictal phenomena?Secondary research questions:- Does treatment with…
- To evaluate the relative bioavailability between the new eltrombopag capsule formulation (CPS) and the marketed tablet formulation (FCT) at single oral doses of 25 mg and 75 mg, in healthy subjects in the fasted state.- To evaluate the PK…
Primary: To evaluate the efficacy of eltrombopag + cyclosporine as first-line therapy on overall hematologic response (neutrophil, platelet, hemoglobin) by 6 months.Secondary: Overall hematologic response (neutrophil, platelet, hemoglobin) by 3 and…
To investigate if a high loading dose of 2 grams paracetamol has a beneficial effect on pain sensation or has an opioid-sparing effect in patients with pain in the Emergency Department
To compare the effect of eltrombopag and IVIG on the achievement of the platelet count threshold before and after surgery.
Primary:• To show the superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC) with regard to prevention of disease progression assessed by liver histology and by partial…
To characterize the PK of eltrombopag at steady state after oral administration in pediatric patients with SAA.Secondary (key only, see protocol page 40-41 for all objectives): Safety and tolerability. Efficacy (overall response rate ORR).
To assess the effect of a Roux-en-Y gastric bypass on the pharmacokinetics of a single oral dose of 1000 mg paracetamol before the surgery. within one month after the surgery and 6 months after the surgery.
The purpose of this study is to assess the efficacy and safety of ianalumab (VAY736) compared to placebo in addition to second-line eltrombopag in adults with primary immune thrombocytopenia