Trial · NCT01694849
Outcomes48
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 48
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Analysis was done of the efficacy evaluable sample, (Efficacy Evaluable Set) formed by participants with liver biopsy available at end-of-treatment and considered as the Intent to Treat population in the protocol. Robustness analysis was also performed in the Full Analysis Set, formed by all randomized participants that received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | NAS score | MEAN |
| SECONDARY | Number of Participants With Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score of at Least 2 Points | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Decrease in Steatosis Score of at Least 1 Point Between Baseline and Week 52 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Decrease in Lobular Inflammation Score of at Least 1 Point Between Baseline and Week 52 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Title: Number of Participants With Decrease in Ballooning Score of at Least 1 Point Between Baseline and Week 52 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes From Baseline to Week 52 in the Stages of Fibrosis | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | Change in fibrosis score | MEAN |
| SECONDARY | Changes From Baseline to Visit 8 (Week 52) in Liver Enzymes | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | U/L | MEAN |
| SECONDARY | Changes From Baseline to Visit 8 (Week 52) in Aspartate Transaminase/Alanine Aminotransferase Ratio | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | ratio | MEAN |
| SECONDARY | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK 18-M65 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | U/L | MEAN |
| SECONDARY | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK18 M30 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | pmol/L | MEAN |
| SECONDARY | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Adiponectin | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | μg/mL | MEAN |
| SECONDARY | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Ferritin | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | μg/L | MEAN |
| SECONDARY | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: FG19 and FG21 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | pg/mL | MEAN |
| SECONDARY | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Alpha2 Macroglobulin | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | g/L | MEAN |
| SECONDARY | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Hyaluronic Acid, N-terminal Pro-peptide of Collagen Type III (PIIINP), and Tissue Inhibitor of Matrix Metalloprotease-1 (TIMP-1) | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | ng/mL | MEAN |
| SECONDARY | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrotest | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | score on a scale | MEAN |
| SECONDARY | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Steatotest | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | score on a scale | MEAN |
| SECONDARY | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | score on a scale | MEAN |
| SECONDARY | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Enhanced Liver Fibrosis (ELF) | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | score on a scale | 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.
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