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Trial · NCT06596642

Registered outcomes28

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

ListOutcomeTime frameDescription
PrimaryNumber of Red Blood Cell (RBC) transfusion units received by participantsBaseline, every 3 weeks thereafter until week 96
PrimaryParticipant hemoglobin (Hb) level resultsBaseline, every 3 weeks thereafter until week 96
PrimaryParticipant serum ferritin resultsBaseline, week 12, 24, 36, 48, 60, 72, 84 and 96
SecondaryParticipant platelet level resultsBaseline, and every 3 weeks thereafter up to week 96
SecondaryParticipant white blood cell count resultsBaseline, and every 3 weeks thereafter up to week 96
SecondaryParticipant reticulocytes/normoblast count resultsBaseline, and weeks 12, 24, 36, 48, 60, 72, 84 and 96
SecondaryParticipant Hemoglobin F (HbF) levelsBaseline and weeks 6 and 12
SecondaryParticipant uric acid level resultsBaseline, and weeks 12, 24, 36, 48, 60, 72, 84 and 96
SecondaryParticipant lactate dehydrogenase (LDH) level resultsBaseline, and weeks 12, 24, 36, 48, 60, 72, 84 and 96
SecondaryParticipant aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratioBaseline, and weeks 12, 24, 36, 48, 60, 72, 84 and 96
SecondaryParticipant creatinine level resultsBaseline, and weeks 12, 24, 36, 48, 60, 72, 84 and 96
SecondaryParticipant bilirubin (total and direct) laboratory valuesBaseline, and weeks 12, 24, 36, 48, 60, 72, 84 and 96
SecondaryType of iron chelating therapy prescribed to participantsBaseline, every 3 weeks thereafter until week 96
SecondaryIron chelating therapy treatment dosage prescribed to participantsBaseline, every 3 weeks thereafter until week 96
SecondaryParticipant Adverse Events (AEs)Baseline and every 3 weeks until week 12, then weeks 24, 36, 48, 60, 72, 84 and 96
SecondaryParticipant health-related quality of life as assessed by Transfusion-dependent Quality of Life (TranQoL) questionnaireBaseline, week 12, 24, 48, 72 and 96
SecondaryParticipant health-related quality of life as assessed by EQ-5D-5L questionnaireBaseline, week 12, 24, 48, 72 and 96
SecondaryLuspatercept treatment dosage prescribed to participantsBaseline, every 3 weeks thereafter until week 96
SecondaryDuration of luspatercept treatmentBaseline, every 3 weeks thereafter until week 96
SecondaryParticipant reason(s) for luspatercept treatment discontinuation as assessed by the treating clinicianBaseline, every 3 weeks thereafter until week 96

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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