Trial · NCT00550862
Outcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 37
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double-blind Phase: Percent Change From Baseline in Serum Alkaline Phosphatase (ALP) | Baseline and Up to Day 85 | Modified Intent-to-Treat (mITT) Population (N=161) comprised of all randomized participants who received at least 1 dose of investigational product and had at least 1 post-Baseline ALP evaluation taken ≤7 days after their last dose of investigational product. | Percent change | MEAN |
| SECONDARY | Double-blind Phase: Absolute Values for Serum ALP, Aspartate Aminotransferase (AST), Alanine Transaminase (ALT) and Gamma-glutamyl Transferase (GGT) Levels | Baseline and at Days 15, 29, 57 and 85 | Intent-to-Treat (ITT) Population (N=165) comprises all randomized participants who received at least 1 dose of investigational product. Only those participants with data available at specified timepoints has been presented. | Units per liter | MEAN |
| SECONDARY | Double-blind Phase: Percent Change From Baseline in Serum ALP, AST, ALT and GGT Levels | Baseline and at Days 15, 29, 57 and 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented (n=164). | Percent change | MEAN |
| SECONDARY | LTSE Phase: Mean Percent Change From Baseline in Serum ALP, AST, ALT and GGT Levels | Baseline and at 3, 6, 9 and 12 Months | Safety Population (N=78) comprised of all randomized participants who received at least 1 dose of investigational product. Only those participants with data available at specified timepoints has been presented (n=69). | Percent change | MEAN |
| SECONDARY | Double-blind Phase: Absolute Values for Albumin Levels | Baseline and at Days 15, 29, 57 and 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented. | Grams per liter | MEAN |
| SECONDARY | Double-blind Phase: Percent Change From Baseline in Albumin Levels | Baseline and at Days 15, 29, 57 and 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented. | Percent change | MEAN |
| SECONDARY | Double-blind Phase: Absolute Values for Conjugated (Direct) Bilirubin | Baseline and at Days 15, 29, 57 and 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented. | Micromoles per liter | MEAN |
| SECONDARY | Double-blind Phase: Percent Change From Baseline in Conjugated (Direct) Bilirubin | Baseline and at Days 15, 29, 57 and 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented (n=164). | Percent change | MEAN |
| SECONDARY | LTSE Phase: Mean Percent Change From Baseline in Total and Conjugated (Direct) Bilirubin | Baseline and at 3, 6, 9 and 12 Months | Safety Population (N=78). Only those participants with data available at specified timepoints has been presented (n=69) | Percent change | MEAN |
| SECONDARY | Double-blind Phase: Change From Baseline in Enhanced Liver Fibrosis (ELF) Score | Baseline and up to Day 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented (n=146). | Scores on a scale | MEAN |
| SECONDARY | Double-blind Phase: Change From Baseline in HA, P3NP, and TIMP-1 Levels | Baseline and Up to Day 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented (n=146). | Nanograms per milliliter | MEAN |
| SECONDARY | Double-blind Phase: Absolute Values for Biomarkers of Hepatic Inflammation: C-reactive Protein | Baseline and Up to Day 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented (n-144). | Milligrams per milliliter | MEAN |
| SECONDARY | Double-blind Phase: Change From Baseline Values for Biomarkers of Hepatic Inflammation: C-reactive Protein | Baseline and Up to Day 85 | ITT Population (N=165). Only those participants with data available at specified time points has been presented (n=114). | Milligrams per milliliter | MEAN |
| SECONDARY | Double-blind Phase: Absolute Values for Biomarkers of Hepatic Inflammation: Non-essential Fatty Acid (NEFA) | Baseline and Up to Day 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented (n=143). | Millimoles per liter | MEAN |
| SECONDARY | Double-blind Phase: Change From Baseline Values for Biomarkers of Hepatic Inflammation: NEFA | Baseline and Up to Day 85 | ITT Population (N=165). Only those participants with data available at specified time points has been presented (n=112). | Millimoles per liter | MEAN |
| SECONDARY | Double-blind Phase: Absolute Values for Biomarkers of Hepatic Inflammation: Tumor Necrosis Factor Alpha (TNF-alpha) | Baseline and Up to Day 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented (n=144). | Nanograms per liter | MEAN |
| SECONDARY | Double-blind Phase: Change From Baseline Values for Biomarkers of Hepatic Inflammation: TNF-alpha | Baseline and Up to Day 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented (n=119). | Nanograms per liter | MEAN |
| SECONDARY | Double-blind Phase: Absolute Values for Biomarkers of Hepatic Inflammation: TNF-beta and Tumor Growth Factor Beta (TGF-beta) | Baseline and Up to Day 85 | ITT Population (N-165). Only those participants with data available at specified timepoints has been presented (142). | Picomoles per liter | MEAN |
| SECONDARY | Double-blind Phase: Change From Baseline Values for Biomarkers of Hepatic Inflammation: TNF-beta and TGF-beta | Baseline and Up to Day 85 | ITT Population (N=165). Only those participants with data available at specified time points has been presented (n=120). | Picomoles per liter | MEAN |
| SECONDARY | Double-blind Phase: Absolute Values for Biomarkers of Hepatic Inflammation: Bile Acids and Glutathion | Baseline and Up to Day 85 | ITT Population (N=165). Only those participants with data available at specified timepoints has been presented (n=144). | Micromoles per liter | MEAN |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00550862/outcomes