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Trial · NCT04687072

Registered outcomes24

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

ListOutcomeTime frameDescription
SecondaryIncidence and Prevalence of Neutralizing Antibodies (NAb) to Efgartigimod and/or rHuPH20 in the Overall PopulationUp to 35 weeks
Samples were tested for the presence of NAb against efgartigimod and/or rHuPH20 and titers for NAb against rHuPH20. NAb incidence is defined as the total percentage of participants with participant classification "baseline negative-postbaseline positive" and "baseline positive-postbaseline positive". NAb prevalence is defined as the total percentage of participants with participant classification "baseline negative-postbaseline positive," "baseline positive-postbaseline positive," or "baseline positive-postbaseline negative".
SecondarySerum Efgartigimod Trough Concentration (Ctrough) in the Overall PopulationPredose on Weeks 1, 2, 3, 17, 19, 21, 23, and 24All pharmacokinetic (PK) samples were collected predose, on the day of IMP administration.
SecondaryPercentage Change From Baseline in Total IgG in the Overall PopulationBaseline and Weeks 1, 2, 3, 17, 19, 21, 23, and 24Samples were collected predose, on the day of IMP administration.
SecondaryNumber of Participants With Antiplatelet Antibodies in the Overall PopulationWeeks 7, 15, 23, and 24The antiplatelet antibody was positive if optical density value \>0.129.

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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