Trial · NCT01265498
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 48
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) | baseline to 72 weeks | Centrally scored histological improvement in nonalcoholic fatty liver disease (NAFLD) from baseline to the end of 72 weeks of treatment, where improvement is defined as: 1. No worsening in fibrosis; and 2. A decrease in NAFLD Activity Score (NAS) of at least 2 points |
| Secondary | Resolution of NASH Diagnosis | baseline to 72 weeks | Resolution of definite nonalcoholic steatohepatitis. Resolution defined as either not NAFLD, or NAFLD but not non-alcoholic steatohepatitis on week 72 biopsy |
| Secondary | Fibrosis: Patient With Improvement | baseline to 72 weeks | Patients with improvement in fibrosis score. Fibrosis was assessed on a scale of 0-4, with higher scores showing more severe fibrosis. |
| Secondary | Fibrosis: Change in Score | baseline to 72 weeks | Change in fibrosis score. Fibrosis was assessed on a scale of 0-4, with higher scores showing more severe fibrosis. |
| Secondary | Total NAFLD Activity Score: Change in Score | baseline to 72 weeks | NAFLD activity score was assessed on a scale of 0-8, with higher scores showing more severe disease (the components of this measure are steatosis \[assessed on a scale of 0-3\], lobular inflammation \[assessed on a scale of 0-3\], and hepatocellular ballooning \[assessed on a scale of 0-2\]). |
| Secondary | Hepatocellular Ballooning: Patients With Improvement | baseline to 72 weeks | Patients with improvement in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0-2, with higher scores showing more severe ballooning. |
| Secondary | Hepatocellular Ballooning: Change in Score | baseline to 72 weeks | Change in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0-2, with higher scores showing more severe ballooning. |
| Secondary | Steatosis: Patients With Improvement | baseline to 72 weeks | Patients with improvement in steatosis score. Steatosis was assessed on a scale of 0-3, with higher scores showing more severe steatosis. |
| Secondary | Steatosis: Change in Score | baseline to 72 weeks | Change in steatosis score. Steatosis was assessed on a scale of 0-3, with higher scores showing more severe steatosis. |
| Secondary | Lobular Inflammation: Patients With Improvement | baseline to 72 weeks | Patients with improvement in lobular inflammation score. Lobular inflammation was assessed on a scale of 0-3, with higher scores showing more severe lobular inflammation. |
| Secondary | Lobular Inflammation: Change in Score | baseline to 72 weeks | Change in lobular inflammation score. Lobular inflammation was assessed on a scale of 0-3, with higher scores showing more severe lobular inflammation. |
| Secondary | Portal Inflammation: Patients With Improvement | baseline to 72 weeks | Patients with improvement in portal inflammation score. Portal inflammation was assessed on a scale of 0-2, with higher scores showing more severe portal inflammation. |
| Secondary | Portal Inflammation: Change in Score | baseline to 72 weeks | Change in portal inflammation score. Portal inflammation was assessed on a scale of 0-3, with higher scores showing more severe portal inflammation. |
| Secondary | Change in Alanine Aminotransferase | baseline to 72 weeks | |
| Secondary | Change in Asparate Aminotransferase | baseline to 72 weeks | |
| Secondary | Change in Alkaline Phosphatase | baseline to 72 weeks | |
| Secondary | Change in γ-glutamyl Transpeptidase | baseline to 72 weeks | |
| Secondary | Change in Total Bilirubin | baseline to 72 weeks | |
| Secondary | Change in Total Cholesterol | baseline to 72 weeks | |
| Secondary | Change in HDL Cholesterol | baseline to 72 weeks |
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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