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Trial · NCT07476625

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryProportion of Participants Achieving Complete Remission at 6 Months6 monthsComplete remission is defined as the total absence of febrile episodes (zero attacks) during the treatment period.
SecondaryComplete Remission Rate at Multiple Time Points3 monthsProportion of participants with zero febrile episodes.
SecondaryComplete Remission Rate at Multiple Time Points9 monthsProportion of participants with zero febrile episodes.
SecondaryComplete Remission Rate at Multiple Time Points12 monthsProportion of participants with zero febrile episodes.
SecondaryPartial Remission Rate3 monthsProportion of participants achieving a reduction in the frequency of febrile episodes compared to baseline.
SecondaryRecurrence Rate Post-discontinuation6 months post-treatmentProportion of participants experiencing a relapse of symptoms after stopping the medication.
SecondaryRecurrence Rate Post-discontinuation12 months post-treatmentProportion of participants experiencing a relapse of symptoms after stopping the medication.
SecondaryChange in Growth Parameters (Z-scores)6 monthsChanges in Height-for-age Z-score (HAZ) and Weight-for-age Z-score (WAZ).
SecondaryChange in Growth Parameters (Z-scores)12 monthsChanges in Height-for-age Z-score (HAZ) and Weight-for-age Z-score (WAZ).
SecondaryChange in Inflammatory Markers6 monthsChanges in CRP, ESR, SAA, and cytokine levels.
OtherIncidence of Adverse Events1 monthPercentage of participants experiencing diarrhea, abdominal pain, nausea, liver function abnormality, somnolence, constipation, rash, or peripheral neuropathy (numbness).
OtherIncidence of Adverse Events6 monthsPercentage of participants experiencing diarrhea, abdominal pain, nausea, liver function abnormality, somnolence, constipation, rash, or peripheral neuropathy (numbness).
OtherIncidence of Adverse Events12 monthsPercentage of participants experiencing diarrhea, abdominal pain, nausea, liver function abnormality, somnolence, constipation, rash, or peripheral neuropathy (numbness).
OtherQuality of Life (PedsQL-SF15)6 monthsChange in Pediatric Quality of Life Inventory Short Form 15 scores.
OtherQuality of Life (PedsQL-SF15)12 monthsChange in Pediatric Quality of Life Inventory Short Form 15 scores.

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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