6 results
Primairy objective:• To determine the safety, tolerability and pharmacokinetics of 2B3-201, and in comparison to free methylprednisolone hemisuccinate and placebo;Secundairy objective:• To determine the pharmacodynamic effects of 2B3-201 on CNS…
During the course of the study 2 randomisation questions will be adressed. Both questions concern patients in the high risk group.Randomisation question 1: Will the addition of Doxorubicin to the first 4 standard IVA chemotherapy courses lead to a…
Primary Efficacy Objective:To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing the American College of Rheumatology (ACR) Provisional Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS)…
The main objective of this trial is to assess whether treatment adaptation based on a very early FDG-PET results in improved efficacy while minimizing treatment toxicity in advanced stage HL patients treated with BV-containing regimens, BrAVD and…
To assess the proportion of UTUC patients with adequate renal function and fit to receive either neo- or adjuvant cisplatin-based chemotherapy treatment To assess the proportion of UTUC patients randomized to neo- or adjuvant chemotherapy that is…
Primary efficacy objectives:To evaluate the efficacy of lenabasum 20 mg twice per day (BID) compared to placebo in the treatment of cystic fibrosis (CF) by assessing the rate of pulmonary exacerbations (PEx) using primary definition of PEx.Secondary…