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Trial · NCT03226067

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYThe Percent Change in Serum GGT.Baseline to week 24 (visit 7)Number of subjects analyzed in the Intent to Treat population who have evaluable resultspercent changeMEAN
SECONDARYAbsolute Change in Serum GGTFrom baseline to Weeks 2, 6, 12, 18 and 24Number of subjects analyzed in the Intent to Treat population who have evaluable resultsU/LMEAN
SECONDARYPercent Change in Serum GGTFrom baseline to Weeks 2, 6, 12, 18 and 24Number of subjects analyzed in the Intent to Treat population who have evaluable resultspercent changeMEAN
SECONDARYPercent Change in Serum ALPFrom baseline to Weeks 2, 6, 12, 18 and 24Number of subjects analyzed in the Intent to Treat population who have evaluable resultspercent changeMEAN
SECONDARYAbsolute Change in Serum ALPFrom baseline to Weeks 2, 6, 12, 18 and 24Number of subjects analyzed in the Intent to Treat population who have evaluable resultsU/LMEAN
SECONDARYAbsolute Change in Serum Conjugated Bilirubin.From baseline to Weeks 2, 6, 12, 18 and 24Number of subjects analyzed in the Intent to Treat population who have evaluable resultsμmol/LMEAN
SECONDARYPercent Change in Serum Conjugated Bilirubin.From baseline to Weeks 2, 6, 12, 18 and 24Number of subjects analyzed in the Intent to Treat population who have evaluable resultspercent changeMEAN
SECONDARYAbsolute Change in Serum Total Bilirubin.from baseline to Weeks 2, 6, 12, 18 and 24Number of subjects analyzed in the Intent to Treat population who have evaluable resultsμmol/LMEAN
SECONDARYPercent Change in Serum Total Bilirubin.from baseline to Weeks 2, 6, 12, 18 and 24Number of subjects analyzed in the Intent to Treat population who have evaluable resultspercent changeMEAN
SECONDARYAbsolute Change in Liver Stiffness as Assessed by Transient Elastography (FibroScan® or Similar Technology).From baseline to Week 24, in patients with values at baseline and Week 24.Number of subjects analyzed in the Intent to Treat population who have evaluable resultskPaMEAN
SECONDARYPercent Change in Liver Stiffness as Assessed by Transient Elastography (FibroScan® or Similar Technology).From baseline to Week 24, in patients with values at baseline and Week 24.Number of subjects analyzed in the Intent to Treat population who have evaluable resultspercent changeMEAN
SECONDARYPercent Change in Serum Levels of Collagen Fragments Indicative of Collagen Formation and Degradation.From baseline to Weeks 12 and 24.Number of subjects analyzed in the Intent to Treat population who have evaluable resultspercent changeMEAN
SECONDARYAbsolute Change in Liver Stiffness as Assessed by Transient Elastography by Subgroup (FibroScan® or Similar Technology).From baseline to Week 24, in patients with values at baseline and Week 24.Number of subjects analyzed in the Intent to Treat population who have evaluable resultskPaMEAN
SECONDARYPercent Change in Liver Stiffness as Assessed by Transient Elastography by Subgroup (FibroScan® or Similar Technology).From baseline to Week 24, in patients with values at baseline and Week 24.Number of subjects analyzed in the Intent to Treat population who have evaluable resultspercent changeMEAN
SECONDARYAbsolute Change in Pruritis Visual Analogue Scale (VAS) ScoresFrom baseline to Weeks 12 and 24Number of subjects analyzed in the Intent to Treat population who have evaluable resultsscore on a scaleMEAN
SECONDARYPercent Change in Pruritis Visual Analogue Scale (VAS) ScoresFrom baseline to Weeks 12 and 24Number of subjects analyzed in the Intent to Treat population who have evaluable resultspercent changeMEAN
SECONDARYAbsolute Change in PBC-40 (Primary Biliary Cholongitis) Domain ScoresFrom baseline to Weeks 12 and 24Number of subjects analyzed in the Intent to Treat population who have evaluable resultsscore on a scaleMEAN
SECONDARYPercent Change in PBC-40 (Primary Biliary Cholongitis) Domain ScoresFrom baseline to Weeks 12 and 24Number of subjects analyzed in the Intent to Treat population who have evaluable resultspercent changeMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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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