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Trial · NCT06544499

Registered outcomes29

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Secondary
In participants receiving placebo IV in the DBTP, the extent of disease control, defined as the number of cumulative weeks with platelet counts of at least 50 × 10^9/L during the first 24 weeks of treatment with efgartigimod IV
Up to 24 weeks
SecondaryOccurrence rate of rescue ITP therapyUp to 76 weeks
SecondaryProportion of participants with reduction in concurrent ITP therapy during the OLTP1Up to 52 weeks
SecondaryIncidence and severity of bleeding, assessed by the ITP Bleeding Scale (IBLS)Up to 76 weeks
SecondaryIncidence of AEs (including AEs of clinical interest) and SAEsUp to 136 weeks
AE = adverse event; SAE = serious adverse event; An adverse event of clinical interest is a pre-specified medically significant event that has the potential to be causally associated with the study drug.
SecondaryIncidence of ADA against efgartigimod in serum over timeUp to 136 weeksADA = antidrug antibodies
SecondaryIncidence of NAb against efgartigimod in serum over timeUp to 136 weeksNAb = Neutralizing antibodies
SecondaryEfgartigimod Cmax over timeUp to 136 weeks
SecondaryPercent change from baseline in total IgG levels in serum over timeUp to 136 weeksIgG = immunoglobulin G

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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