6 results
The primary objective (on lesion-based analysis) is to show that pre-treatment 89Zr-trastuzumab PET/CT is able to select lesions not responding morphologically from treatment with T-DM1 (applying RECIST 1.0 criteria)Secondary Objectives and…
Primary Objectives:Use 89Zr-Trastuzumab to characterise the in vivo biodistribution using PET imaging in the primary tumour and distant metastases.Comparie the uptake in patients with Her2/neu positive breast cancer to patients with HER2/neu…
The main goal of the proposed project is to compare two MTX dosing regimens to suppress ADA levels in patients with inflammatory bowel disease (IBD) with loss of response to anti-TNF agents, and to relate these findings to clinical and biochemical…
- To compare the pharmacokinetics (PK) of glepaglutide after a single subcutaneous (SC) administration by vial/syringe and by autoinjector.- To evaluate the safety and tolerability of glepaglutide following SC dosing in healthy subjects.
5.1 Primary ObjectiveTo confirm the efficacy of glepaglutide in reducing PS volume in SBS patients.5.2 Secondary ObjectivesTo evaluate the efficacy of glepaglutide on other efficacy endpoints in patients with SBS.To evaluate the safety and…
5.1 Primary ObjectiveTo evaluate the long-term safety of glepaglutide treatment in SBS patients.5.2 Secondary ObjectivesTo evaluate the long-term efficacy of glepaglutide treatment in SBS patients.To evaluate the long-term immunogenicity of…