Status and phase
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About
This is an open-label long-term multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in adult patients with primary ITP.
Enrollment
Sex
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Volunteers
Inclusion criteria
Ability to understand the requirements of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).
Patients enrolled in the ARGX-113-1801 trial who completed the 24-weeks trial period.
Women of childbearing potential must have a negative urine pregnancy test at baseline before trial medication (infusion) can be administered.
Women of childbearing potential should use a highly effective or acceptable method of contraception during the trial and for 90 days after the last administration of the IMP. They must be on a stable regimen, for at least 1 month (as listed in the protocol)
Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).
Patient has completed a 52-week treatment period.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
101 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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