5 results
To investigate the safety, tolerability and behavior in the body (absorption and excretion) of oral intake of TMC589337 and TMC589354 after ascending single intakes. In addition, the safety, tolerability and behavior in the body after multipe dose…
Objectives safety run-in: The primary objective is:• To assess the safety of i.v. teicoplanin prophylaxis three times per week with a two to three days interval in children with newly-diagnosed AML. A patient will be considered evaluable for safety…
• To assess the efficacy of rozanolixizumab as measured by seizure freedom• To assess the efficacy of ozanolixizumab as measured by change in cognitive function• To assess the efficacy of ozanolixizumab as measured by use of rescue medication• To…
The primary objective of the study is:• To evaluate the clinical efficacy of rozanolixizumab as a treatment for subjects with CIDPThe secondary objectives of the study are:• To evaluate the safety and tolerability of rozanolixizumab sc infusion in…
CIDP04 is a Phase 2A, multicenter, single-arm, open-label study with the primary objective of evaluating the long-term safety and tolerability of rozanolixizumab when administered as weekly subcutaneous (sc) infusion in subjects with CIDP. The…