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Trial · NCT06431776

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryDLCO24 weeksChange in Hb-adjusted % predicted DLCO from Baseline.
SecondaryDLCO48-weeksChange in Hb-adjusted % predicted DLCO from Baseline .
Secondary6-minute walk distance24-weeksAbsolute change from Baseline in 6-minute walk distance (6MWD)
Secondary6-minute walk distance48-weeksAbsolute change from Baseline in 6-minute walk distance (6MWD).
SecondaryPedsQL24-weeksChange from Baseline in Pediatric Quality of Life (PedsQLTM) Generic Core Scale score.
SecondaryPedsQL48-weeksChange from Baseline in Pediatric Quality of Life (PedsQLTM) Generic Core Scale score.
SecondaryOxygen Saturation (SpO2)24 weeksAbsolute change from Baseline in oxygen saturation (SpO2)
SecondaryOxygen Saturation (SpO2)48 weeksAbsolute change from Baseline in oxygen saturation (SpO2)
OtherAdverse Events48 weeks
Adverse events (AEs), including clinically significant findings on pulmonary function tests and safety laboratory assessments and adverse events of special interest (AESIs; hypersensitivity and chest pain).
OtherAnti-GM-CSF Ab titer0, 4, 12,24,48 and 52 weeksTiters of anti-GM-CSF antibodies
OtherFEV124 and 48-weeksChange from Baseline in forced expiratory volume in one second (FEV1) (% predicted)
OtherFVC24 and 48-weeksChange from Baseline in Forced vital capacity (FVC) (% predicted)

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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