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Trial · NCT03408132

Registered outcomes14

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

ListOutcomeTime frameDescription
PrimaryIncidence of treatment-emergent adverse eventsDay -28 to Day 26 plus 6 weeksAdverse events as assessed by CTCAE v4.03
SecondaryAssessment of intestinal insufficiency and gut absorptionDay -28 to day 26Changes in the wet weight (g) of faecal excretion
SecondaryAssessment of intestinal insufficiency and gut absorptionDay -28 and day 26Changes from baseline in lean body mass by DEXA scan.
SecondaryAssessment of intestinal insufficiency and gut absorptionDay -28 and day 26Changes from baseline in bone mineral content by DEXA scan.
SecondaryAssessment of intestinal insufficiency and gut absorptionDay -28 and day 26Changes from baseline in fat mass by DEXA scan.
SecondaryAssessment of intestinal insufficiency and gut absorptionDay -28 to day 26 plus 6 weeksMeasure of body weight (kg)
SecondaryAssessment of intestinal insufficiency and gut absorptionBaseline (Day -6) to end of treatment (Day 26)Measurement of urinary output (ml)
SecondaryAssessment of intestinal insufficiency and gut absorptionBaseline (Day -6) to end of treatment (Day 26)Measurement of urinary electrolytes (sodium, potassium, calcium, magnesium) (mmol/d)
SecondaryAssessment of gut regenerationBaseline (Day -7) to end of treatment period (Day 26) plus 6 weeksMeasurements of the plasma Citrulline (ng/ml)
SecondaryMaximum observed plasma concentration (Cmax)Day 1 to end of treatment period (Day 26)Cmax (ng/ml)
SecondaryCumulative area under the plasma concentration (AUC) of FE 203799 from time 0 to 168Day 1 to end of treatment period (Day 26)AUC0-168 (ng\*hr/ml)
SecondaryTerminal elimination half-life (T1/2) of FE 203799Day 1 to end of treatment period (Day 26)T1/2 (h)
SecondaryApparent total body clearance (CL) of FE 203799 from plasmaDay 1 to end of treatment period (Day 26)CL (ml/hr)
SecondaryApparent volume of distribution (Vd) of FE 203799 during terminal phaseDay 1 to end of treatment period (Day 26)Vd (ml)

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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