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A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2)
Primary Outcome Measures :
Time from randomization until treatment failure [ Time Frame: Randomization to until end of study (up to 39 months after randomization of last participant) ]
Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure:
platelet count below 30 G/L
start of a new ITP treatment
need for a rescue treatment
ineligibility to taper or inability to discontinue eltrombopag
death
Primary Outcome Measures :
Time from randomization until treatment failure [ Time Frame: Randomization to until end of study (up to 39 months after randomization of last participant) ]
Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure:
platelet count below 30 G/L
start of a new ITP treatment
need for a rescue treatment
ineligibility to taper or inability to discontinue eltrombopag
death
Recruitment Status
Current Studies