A phase 3, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia
Brief description of study
To demonstrate that the addition of ianalumab to standard first-line corticosteroids prolongs Time to Treatment Failure compared to Corticosteroids alone in participants with primary ITP.
ITP means immune thrombocytopenia. Time from randomization to treatment failure which is defined as Platelet count below 30G/L after 8 weeks from randomization.
Need for a rescue treatment after 8 weeks from randomization.
Start of a second-line therapy or death. Complete response rate at each time point which is defined as the proportion of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment.
Response rate at each timepoint which is defined as the proportion of participants with any platelet count of at least 50 G/L in the absence of rescue treatment or new ITP treatment.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Medical Research
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Age: - 99 Years
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Gender: All
TBD
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