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Trial · NCT06392386

Registered outcomes30

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

ListOutcomeTime frameDescription
PrimaryEfgartigimod serum concentrations as input for compartmental, model-driven analysis to determine age and size dependency of Clearance (CL)Up to 12 weeks
PrimaryEfgartigimod serum concentrations as input for compartmental, model-driven analysis to determine age and size dependency of Volume Distribution (Vd)Up to 12 weeks
PrimaryTotal G immunoglobulins (IgG) levels as input for pharmacokinetics (PK)/pharmacodynamics (PD) modelling analysisUp to 12 weeks
PrimaryAnti-acetylcholine receptors antibodies (AChR-Ab) as input for pharmacokinetics (PK)/ pharmacodynamics (PD) modelling analysisUp to 12 weeks
SecondaryIncidence of adverse events (AEs)Up to 14 weeks
SecondarySeverity of adverse events (AEs)Up to 14 weeks
SecondaryIncidence of serious adverse events (SAEs)Up to 14 weeks
SecondarySeverity of serious adverse events (SAEs)Up to 14 weeks
SecondaryIncidence of adverse events of special interest (AESI)Up to 14 weeks
SecondarySeverity of adverse events of special interest (AESI)Up to 14 weeks
SecondaryEfgartigimod serum concentrationsUp to 12 weeks
SecondaryAbsolute values of total Immunoglobulin G (IgG) from blood samplesUp to 12 weeks
SecondaryChange from baseline values of total Immunoglobulin G (IgG) from blood samplesUp to 12 weeks
SecondaryPercentage change from baseline values of total Immunoglobulin G (IgG) from blood samplesUp to 12 weeks
SecondaryAbsolute values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samplesUp to 12 weeks
SecondaryChange from baseline values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samplesUp to 12 weeks
SecondaryPercentage change from baseline values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samplesUp to 12 weeks
SecondaryIncidence of anti-drug antibodies (ADAs) against efgartigimod in serum samplesUp to 12 weeks
SecondaryPrevalence of anti-drug antibodies (ADAs) against efgartigimod in serum samplesUp to 12 weeks
SecondaryIncidence of antibodies against rHuPH20 in serum samplesUp to 12 weeks

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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