5 results
A study to investigate the safety, pharmacokinetics and pharmacodynamics of a new recombinant human factor VIIa in healthy males, compared to Novoseven.
- to evaluate the FVIIa activity PK of 2 CSL689 dose levels in subjects with congenital FVII deficiency- to determine the PK characteristics of FVIIa activity of CSL689- to evaluate the safety and tolerability of intravenous administration of CSL689
Primary: To evaluate the efficacy of tisagenlecleucel therapy as measured by overall response rate by investigator assessment.Secondary: Duration of response, event free survival, relapse free survival, overall survival, safety, kinetics,…
The study will be performed in 2 parts, Part 1 and Part 2. Part 2 has been clinically completed. The remainder of this document concerns Part 1 only. The purpose of Part 1 of this study is to determine the reversal of the blood thinning effects of…
To compare tisagenlecleucel treatment strategy to SOC treatment strategy with respect to delaying the composite event of disease progression / stable disease at or after the week 12 assessment; or death at any time.