Trial · NCT01473524
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | DB Phase: Composite Endpoint Alkaline Phosphatase (ALP) And Total Bilirubin, 10 mg OCA Versus Placebo | DB Month 12 | Percentage of participants at Month 12 with ALP \< 1.67 x upper limit of normal (ULN) and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline. |
| Primary | LTSE Phase: Composite Endpoint ALP And Total Bilirubin | Baseline (DB Month 12), LTSE Months 24, 36, 48, and 60 | Percentage of participants at Months 24, 36, 48, and 60 with ALP \< 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline. DB Month 12 is the baseline for the LTSE phase. |
| Secondary | DB Phase: Composite Endpoint ALP And Total Bilirubin, 10 mg Versus Placebo | DB Month 6 | Percentage of participants at Month 6 with ALP \< 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline. |
| Secondary | DB Phase: Composite Endpoint ALP And Total Bilirubin, 5-10 mg Versus Placebo | DB Month 12 | Percentage of participants at Month 12 with ALP \< 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline. |
| Secondary | DB Phase: Composite Endpoint ALP And Total Bilirubin, 5-10 mg Versus Placebo | DB Month 6 | Percentage of participants at Month 6 with ALP \< 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline. |
| Secondary | DB Phase: ALP Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Blood samples were evaluated for ALP levels. ALP Absolute Change From Baseline (ALP at Month 12 - ALP at Baseline) is presented. |
| Secondary | DB Phase: Total Bilirubin Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Blood samples were evaluated for bilirubin levels. Total bilirubin absolute change from baseline (total bilirubin at Month 12 - total bilirubin at Baseline) is presented. |
| Secondary | DB Phase: Direct Bilirubin Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Blood samples were evaluated for bilirubin levels. Direct bilirubin absolute change from baseline (direct bilirubin at Month 12 - direct bilirubin at Baseline) is presented. |
| Secondary | DB Phase: Alanine Aminotransferase (ALT) Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Blood samples were evaluated for ALT levels. ALT absolute change from baseline (ALT at Month 12 - ALT at Baseline) is presented. |
| Secondary | DB Phase: Aspartate Aminotransferase (AST) Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Blood samples were evaluated for AST levels. AST absolute change from baseline (AST at Month 12 - AST at Baseline) is presented. |
| Secondary | DB Phase: Gamma-glutamyltransferase (GGT) Absolute Change From Baseline To Month 12 | Baseline, DB Month 12 | Blood samples were evaluated for GGT levels. GGT absolute change from baseline (GGT at Month 12 - GGT at Baseline) is presented. |
| Secondary | LTSE Phase: ALP Levels | LTSE Day 0 and LTSE Months 12, 24, 36, 48, and 60 | Blood samples were evaluated for ALP levels. |
| Secondary | LTSE Phase: ALP Change From DB Baseline | DB Baseline, LTSE Months 12, 24, 36, 48, and 60 | Blood samples were evaluated for ALP levels. ALP Change From Baseline (ALP at LTSE Months 12, 24, 36, 48, and 60 - ALP at Baseline) is presented. DB baseline is the mean of all available evaluations prior to DB treatment. |
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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