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Trial · NCT07393373

Registered outcomes19

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

ListOutcomeTime frameDescription
PrimaryIncidence of treatment emergent adverse events (TEAE) and serious TEAE10 years
PrimaryChanges over time in standing height Z-score in relation to HCH and non-HCH growth charts10 years
SecondaryChanges over time in AHV Z-score10 years
SecondaryChanges over time in body proportions10 years
SecondaryChanges over time in weight Z-score10 years
SecondaryChanges overtime in BMI10 years
SecondaryAge of puberty onset and time to Tanner stage ≥410 years
SecondaryChanges over time in body composition as assessed by DXA (dual x-ray absorptiometry) scans10 years
SecondaryChanges over time in bone morphology/density by x-ray and DXA10 years
SecondaryChange in psychomotor function assessed by age-appropriate computerized tests (Detection Test)10 years
SecondaryChange in attention assessed by age-appropriate computerized tests (Identification Test)10 years
SecondaryChange in visual learning assessed by age-appropriate computerized tests (One Card Learning Test)10 years
SecondaryChange in working memory assessed by age-appropriate computerized tests (One Back Test)10 years
SecondaryChanges over time in severity of epilepsy measured by frequency and adverse event grading10 years
SecondaryChanges in health-related Quality of life [HRQoL] as assessed by Pediatric Quality of Life Inventory (PedsQL)10 years
SecondaryChanges in health-related Quality of life [HRQoL] as assessed by Quality of Life in Short Stature Youth questionnaire (QoLISSY)10 years
SecondarySeverity of the physical functioning challenges as assessed by Patient/Parent Global Impression of Severity (PGI-S)10 years
SecondarySeverity of the physical functioning challenges as assessed by Patient/Parent Global Impression of Change (PGI-C)10 years
SecondarySubject and caregiver evaluation of treatment benefit as assessed by a qualitative interview10 years

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license 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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