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Trial · NCT04925661

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryIncidence of Adverse EventsThrough study completion, an average of 12 weeks.To assess the safety and tolerability of therapy by incidence of treatment-emergent adverse events after multiple doses of HEC53856 capsule
SecondaryAUC0-tDay 1(Dosing) until Day 55 after single and multiple drug dosing.Area under the concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration
SecondaryCmaxDay 1(Dosing) until Day 55 after single and multiple drug dosing.Maximum observed plasma concentration
SecondaryTmaxDay 1(Dosing) until Day 55 after single and multiple drug dosing.Time of the maximum observed plasma concentration
SecondaryT½Day 1(Dosing) until Day 55 after single and multiple drug dosing.Apparent terminal elimination half-life
SecondaryVz/FDay 1(Dosing) until Day 55 after single and multiple drug dosing.Apparent volume of distribution
SecondaryChanges in mean hemoglobinweek 10Changes in mean hemoglobin (Hb) relative to baseline during weeks 8 and 10.
SecondaryHemoglobin responseweek 10Percentage of subjects who met the hemoglobin response after dosing
SecondaryE-AUC0-tDay 1(Dosing) until Day 55 after single and multiple drug dosing.Area under the EPO concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration
SecondaryEmaxDay 1(Dosing) until Day 55 after single and multiple drug dosing.Maximum observed EPO concentration
SecondaryE-TmaxDay 1(Dosing) until Day 55 after single and multiple drug dosing.Time of the maximum observed EPO concentration
SecondarySerum lipidUp to Day 55Changes in Serum lipid relative to baseline at weeks 8.
SecondaryIndicators of ironUp to Day 55Changes in the Indicators of iron relative to baseline at weeks 8.
SecondaryHigh-sensitivity C-reactive proteinUp to Day 55Changes in the High-sensitivity C-reactive protein relative to baseline at weeks 8.
SecondaryReticulocytesUp to Day 85Changes in the mean Reticulocytes relative to baseline after doses.
SecondaryVEGFUp to Day 55Changes in the VEGF relative to baseline after doses.

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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