16 results
Primary Objectives:To assess the incidence and the time to confirmed IFI in subjects treated pre-emptively with micafungin versus placebo.
Primary Objective* To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis Secondary Objectives* To explore skin and faecal microbiome in patients with seborrheic dermatitis * To evaluate the…
A number of anti-HER2 therapies have proven efficacy, are approved and part of the Standard of Care for HER2-positive BC and GC. In contrary, there is currently no clinical data on the potential therapeutic effect of trastuzumab emtansine treatment…
Primary objective:To determine the effect of obesity (BMI > 40kg/m2) on the pharmacokinetics of micafungin and develop a dosing regimen for obese patients. Secondary objective:* To describe the pharmacokinetics of the approved dose of 200mg…
To evaluate the safety and efficacy of once daily application of omiganan topical gel compared to vehicle topical gel in subjects with papulopustular rosacea
To evaluate the long-term safety of omiganan topical gel applied once daily to the face of subjects with papulopustular rosacea
Primary Objective• To explore the pharmacodynamic effects of topically applied omiganan • To explore the treatment effect of omiganan compared to placebo in uVIN patients Secondary Objectives• To assess safety and tolerability • To explore the…
Primary Objectives 1. To evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage and identify covariates…
Primary Objective- To assess efficacy and pharmacodynamic effects of topical omiganan BID Secondary Objectives- To assess safety and tolerability of topical omiganan BID
Primary Objectives* To explore the pharmacodynamic effects of topically applied omiganan in patients with external genital warts* To explore clinical efficacy of omiganan compared to placebo in patients with external genital warts.Secondary…
To evaluate the safety and efficacy of once daily application of omiganan topical gel compared to vehicle topical gel in subjects with papulopustular rosacea.
Primary objective• To explore the pharmacodynamic effects on a target lesion of topically applied omiganan in AD patientsSecondary Objectives• To assess safety and tolerability in AD patients• To evaluate the efficacy of omiganan compared to placebo…
The primary objective of this study is to evaluate the safety and tolerability of trastuzumab emtansine.
Primary objective:1. To evaluate IDFS with T-DXd treatment as compared to T-DM1Secundary objectives:1. To evaluate DFS with T-DXd treatment as compared to T-DM12. To evaluate OS with T-DXd treatment as compared to T-DM13. To evaluate DRFI with T-DXd…
To evaluate efficacy of image-guided de-escalating chemotherapy in the presence of dual HER2-blockade with Herceptin® and pertuzumab in HER2-positive breast cancer, as measured by three-year event-free survival.Secondary objectives• To evaluate 3-…
-To dertermine the objective response rate (ORR) and disease control rate (DCR) (according to RECIST v1.1) after 3 months of treatment with T-DM1 and osimertinib in patients with EGFR mutation positive NSCLC and HER2 bypass track activation-To…