Trial · NCT02177136
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | DB Phase: Change From Baseline In Serum Alkaline Phosphatase (ALP) | Baseline, Week 24 | Intent-to-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | U/L | LEAST_SQUARES_MEAN |
| PRIMARY | LTSE Phase: Incidence Of Adverse Events Of Special Interest (AESIs) | LTSE Baseline (DB Week 24) to Month 26 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DB Phase: Change From Baseline In Serum Alanine Transaminase (ALT) | Baseline, Week 24 | Intent-To-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | U/L | MEDIAN |
| SECONDARY | DB Phase: Change From Baseline In Serum Aspartate Aminotransferase (AST) | Baseline, Week 24 | Intent-to-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | U/L | MEDIAN |
| SECONDARY | DB Phase: Change From Baseline In Serum Total Bilirubin | Baseline, Week 24 | Intent-To-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | umol/L | MEDIAN |
| SECONDARY | DB Phase: Change From Baseline In Serum Direct Bilirubin | Baseline, Week 24 | Intent-To-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | umol/L | MEDIAN |
| SECONDARY | DB Phase: Change From Baseline In Serum Gamma-glutamyl Transferase (GGT) | Baseline, Week 24 | Intent-To-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | U/L | MEDIAN |
| SECONDARY | DB Phase: Change From Baseline In Plasma Fibroblast Growth Factor-19 (FGF-19) | Baseline, Week 24 | Intent-to-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | pg/mL | MEDIAN |
| SECONDARY | DB Phase: Change From Baseline In Plasma 7α-Hydroxy-4-cholesten-3-one (C4) | Baseline, Week 24 | Intent-To-Treat Population: All randomized participants who received any amount of investigational product within the DB phase. | ng/mL | MEDIAN |
| SECONDARY | LTSE Phase: Change From Baseline In Serum ALP At Month 12 | LTSE Baseline (DB Week 24), Month 12 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase and had an efficacy assessment at the specified time points. | U/L | MEDIAN |
| SECONDARY | LTSE Phase: Change From Baseline In Serum ALT At Month 12 | LTSE Baseline (DB Week 24), Month 12 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase and had an efficacy assessment at the specified time points. | U/L | MEDIAN |
| SECONDARY | LTSE Phase: Change From Baseline In Serum AST At Month 12 | LTSE Baseline (DB Week 24), Month 12 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase and had an efficacy assessment at the specified time points. | U/L | MEDIAN |
| SECONDARY | LTSE Phase: Change From Baseline In Serum Total Bilirubin At Month 12 | LTSE Baseline (DB Week 24), Month 12 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase and had an efficacy assessment at the specified time points. | umol/L | MEDIAN |
| SECONDARY | LTSE Phase: Change From Baseline In Serum Direct Bilirubin At Month 12 | LTSE Baseline (DB Week 24), Month 12 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase and had an efficacy assessment at the specified time points. | umol/L | MEDIAN |
| SECONDARY | LTSE Phase: Change From Baseline In Serum GGT At Month 12 | LTSE Baseline (DB Week 24), Month 12 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase and had an efficacy assessment at the specified time points. | U/L | MEDIAN |
| SECONDARY | LTSE Phase: Change From Baseline In Albumin At Month 12 | LTSE Baseline (DB Week 24), Month 12 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase and had an efficacy assessment at the specified time points. | g/L | MEDIAN |
| SECONDARY | LTSE Phase: Change From Baseline In INR At Month 12 | LTSE Baseline (DB Week 24), Month 12 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase and had an efficacy assessment at the specified time points. | Ratio | MEDIAN |
| SECONDARY | LTSE Phase: Change From Baseline In Transient Elastography (TE) At Month 12 | LTSE Baseline (DB Week 24), Month 12 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase and had an efficacy assessment at the specified time points. | kPa | MEDIAN |
| SECONDARY | LTSE Phase: Change From Baseline In Enhanced Liver Fibrosis (ELF) At Month 12 | LTSE Baseline (DB Week 24), Month 12 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase and had an efficacy assessment at the specified time points. | Units on a scale | MEDIAN |
| SECONDARY | LTSE Phase: Change From Baseline In Plasma FGF-19 At Month 12 | LTSE Baseline (DB Week 24), Month 12 | LTSE Population: All participants who received any amount of investigational product during the LTSE phase and had an efficacy assessment at the specified time points. | pg/mL | MEDIAN |
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.
For software
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