4 results
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…
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…
Part 1PrimaryTo assess dose limiting toxicities (DLTs) of EDR to select an RP3D for the combination to be used in Part 2 of this study.Secondary• To evaluate the overall safety profile of EDR to select an RP3D for the combination to be used in Part…
PART B (FL phase IIb *PARADIGME*):Primary objective:Randomised section of Part B- To evaluate the efficacy of the *40/15* dose regimen (40 mg lilotomab / 15 MBq/kg Betalutin) compared with *100/20* dose regimen (100 mg/m2 lilotomab/ 20 MBq/kg…