6 results
Primary objective: To investigate whether pharmacokinetics of the recommended dose of inhaled tobramycin, defined as serum tobramycin Area Under the Curve (AUC0-24hr), with the I-neb (75 mg) is equivalent to the PariLCPlus (300 mg) nebuliser in…
To evaluate the perioperative hemostatic efficacy of BAX 802 in male subjects with CHA with inhibitors to human factor VIII (hFVIII) undergoing major or minor elective surgical, dental, or other invasive procedures as determined by the Global…
Primary objective: To determine the safety of once daily inhalation of the recommended daily dose of tobramycin with the Akita® and the PARI-LC® Plus nebulizer in patients with CF. Systemic absorption can be used as surrogate parameter for safety.…
Primary objective:To compare the change in small airways obstruction (FEF75%) in patients with CF when inhaling one ampule of inhaled tobramycin with the Akita® compared to standard of treatment (twice daily nebulization of one ampule using standard…
The primary objective is:* To determine the overall response rate (ORR) of 4 weekly infusions of obinutuzumab monotherapy (Induction I) in patients with rituximab-refractory follicular lymphoma.The secondary objectives are:* To determine the…
The primary objective of this study is to investigate the potential differential effects of RTX and OBI on the composition of lymph nodes and other target organs (i.e. skin and/or kidney) as well as (subsets of) immune cells in the peripheral blood…