4 results
Primary objective:• Assess the pharmacokinetics (PK) of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary VWDSecundary objectives:• Compare the…
To define and implement an uniform initial evaluation and stratification on adult patients with LCH, to uniform the treatment of adult patients with LCH and to improve treatment results with respect to survival, therapy response, prevention of…
The primary objective of this study is to prospectively evaluate the annualized bleeding rate (ABR) for spontaneous bleeding episodes while on prophylactic treatment with rVWF (vonicog alfa) and to compare it to the subject's historical ABR for…
Phase 1b Dose Escalation Objectives • To determine the safety and tolerability of escalating doses of GB5121• To determine the optimal biological dose (OBD) and/or maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of GB5121 Phase 1b…