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Trial · NCT02117713

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryChange From MRX Baseline to Week 48 in Fasting Serum Bile Acid (sBA)Baseline to Week 48This primacy efficacy endpoint is the mean change from MRX baseline to week 48 in fasting sBA levels.
SecondaryChange From MRX Baseline to Week 216 in Fasting Serum Bile Acid (sBA)Baseline to week 216The secondary endpoint of this study was the mean change from MRX baseline to week 216 fasting in sBA levels.
SecondaryChange From Baseline to Week 218 in PruritusBaseline to Week 218
This secondary efficacy endpoint is the mean change from MRX baseline over time to week 218 in pruritus as measured by ItchRO(Obs) weekly average morning severity score. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity (0 = none; 4 = very severe). Results reported here are the long-term results.
SecondaryChange From Baseline to Week 216 in Alanine AminotransferaseBaseline to week 216This secondary efficacy endpoint is the mean change from MRX baseline to week 216 in ALT levels.
SecondaryChange From Baseline to End of Treatment in Alkaline PhosphataseBaseline to Week 216This secondary efficacy endpoint is the mean change from MRX baseline to week 216 in ALP levels.
SecondaryChange From MRX Baseline to Week 216 in Aspartate AminotransferaseBaseline to week 216This secondary efficacy endpoint is the mean change from MRX baseline to week 216 in AST levels.
SecondaryChange From MRX Baseline to Week 216 in Clinician Xanthoma Severity ScoreBaseline to week 216
This secondary efficacy endpoint is the mean change from MRX baseline to week 216 in clinician xanthoma severity scores. It is based on a 0-4 scale to rate the number of lesions present and the degree to which the lesions interfere or limit activities. Clinician xanthoma severity scores range from 0 to 4, with a score of zero representing no evidence of xanthomatosis and a score of 4 representing xanthoma so severe that it is disabling.
SecondaryChange From Baseline to Week 216/LOFC Clinician Scratch Scale (CSS) ScoreBaseline to Week 216
This secondary efficacy endpoint is the mean change from MRX baseline over time to week 216/LOCF in pruritus as measured by the Clinician Scratch Scale (CSS). The Clinician Scratch Scale uses a 5-point scale, where 0 = none; 1 = rubbing or mild scratching when undistracted; 2 = active scratching without evident skin abrasions; 3 = abrasion evident; 4 = cutaneous mutilation, haemorrhage and scarring evident.
SecondaryChange From MRX Baseline to Week 216 in Gamma GlutamyltransferaseBaseline to Week 216This secondary efficacy endpoint is the mean change from MRX baseline to week 216 in GGT.
SecondaryMean Change From MRX Baseline to Week 216 in Total BilirubinBaseline to week 216This secondary efficacy endpoint is the mean change from MRX baseline to week 216 in total bilirubin.
SecondaryMean Change From MRX Baseline to Week 216 in Direct BilirubinBaseline to week 216This secondary efficacy endpoint is the mean change from MRX baseline to week 216 in direct bilirubin.

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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