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Trial · NCT02704364

Registered outcomes18

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

ListOutcomeTime frameDescription
PrimaryMean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in alkaline phosphatase levels.
SecondaryMean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in alkaline phosphatase levels.
SecondaryMean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing CholangitisBaseline to Week 12
Blood samples were collected to assess rate of change in alkaline phosphatase levels. Serum levels of alkaline phosphatase was measured in a central laboratory using standard enzymatic method. The unit of measure is U/L.
SecondaryMean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.
SecondaryMean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.
SecondaryMean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in bilirubin (direct and total) levels.
SecondaryMean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in bilirubin (direct and total) levels.
SecondaryMean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in gamma glutamyl transferase levels.
SecondaryMean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in gamma glutamyl transferase levels.
SecondaryMean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in cholesterol levels.
SecondaryMean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in cholesterol levels.
SecondaryMean Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.
SecondaryMean Percent Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.
SecondaryMean Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in Prothrombin levels.
SecondaryMean Percent Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in Prothrombin levels.
SecondaryMean Change From Baseline in Calprotectin in Patients With Primary Sclerosing CholangitisBaseline to Week 12Blood samples were collected to assess changes in Calprotectin levels.
SecondaryMean Change From Baseline in Enhanced Liver Fibrosis Score in Patients With Primary Sclerosing CholangitisBaseline to Week 12
Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens). ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome. ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of \<7.7 is none to mild, \> 7.7-9.8 is moderate, \> 9.8 is severe.
SecondarySeverity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing CholangitisBaseline to Week 12
Severity of inflammatory bowel disease (IBD)-associated symptoms and acute cholangitis are summarized with number and percentage. The partial Mayo IBD scale assesses stool frequency, rectal bleeding, and there is a Physician's global assessment. Each section is summed and remission is defined as a total score of 0-1, mild disease 2-4, moderate disease 5-6, and severe disease 7-9. Higher total scores indicate more severe disease. The number of participants are being presented based on the severity of their IBD symptoms.

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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