Trial · NCT01529268
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) | 52 weeks | Centrally scored and masked assessment of histologic improvement in Nonalcholic Fatty Liver Disease (NAFLD) between the baseline liver biopsy and follow-up biopsy after 52 weeks of treatment, where improvement is defined as: (1) decrease in the NAFLD Activity Score (NAS) of 2 or more and (2) no worsening of fibrosis. |
| Secondary | Change in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) | 52 weeks | Change from baseline in the NAFLD Activity Score (NAS), which is a composite score equal to the sum of the steatosis grade (0-3), lobular inflammation grade (0-3), and hepatocellular ballooning grade (0-2), from centralized pathologist scoring of liver biopsies. The overall scale of the NAS is 0-8, with higher scores indicating more severe disease. The outcome measure, change from baseline in NAFLD Activity Score (NAS), has a possible range from -8 to +8, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. Components of the NAS are scored as follows: Steatosis grade 0=\<5% steatosis, 1=5-33% steatosis, 2=34-66% steatosis, 3=\>66% steatosis. Lobular inflammation grade=amount of lobular inflammation (combines mononuclear, fat granulomas, and polymorphonuclear (pmn) foci): 0=0, 1=\<2 under 20x magnification, 2=2-4 under 20x magnification, 3=\>4 under 20x magnification. Hepatocellular ballooning 0=none, 1=mild, 2=more than mild. |
| Secondary | Steatosis: Patients With Improvement | 52 weeks | Improvement in steatosis defined as any decrease in steatosis grade comparing 52-week biopsy to baseline. |
| Secondary | Steatosis: Change in Score | 52 weeks | Change from baseline in steatosis score. Steatosis score is based on central pathologist grading of liver biopsies: 0=\<5% steatosis; 1=5-33% steatosis, 2=34-66% steatosis, 3=\>66% steatosis. Change in steatosis score has a possible range of -3 to +3, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement). |
| Secondary | Lobular Inflammation: Patients With Improvement | 52 weeks | Improvement in lobular inflammation defined as any decrease in lobular inflammation grade comparing 52-week biopsy to baseline. |
| Secondary | Lobular Inflammation: Change in Score | 52 weeks | Change from baseline in lobular inflammation score. The amount of lobular inflammation is based on central pathologist grading of liver biopsies, and combines mononuclear, fat granulomas, and polymorphonuclear (pmn) foci: 0=none; 1=\<2 under 20x magnification, 2=2-4 under 20x magnification, 3=\>4 under 20x magnification. Change in lobular inflammation score has a possible range of -3 to +3, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement). |
| Secondary | Hepatocellular Ballooning: Patients With Improvement | 52 weeks | Improvement in hepatocellular ballooning defined as any decrease in hepatocellular ballooning score comparing 52-week biopsy to baseline. |
| Secondary | Hepatocellular Ballooning: Change in Score | 52 weeks | Change from baseline in hepatocellular ballooning score. The amount of hepatocellular ballooning is based on central pathologist grading of liver biopsies: 0=none; 1=few ballooned hepatocytes, 2=many ballooned hepatocytes. Change in hepatocellular ballooning score has a possible range of -2 to +2, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement). |
| Secondary | Portal Inflammation: Patients With Improvement | 52 weeks | Improvement in portal inflammation defined as any decrease in portal inflammation score comparing 52-week biopsy to baseline. |
| Secondary | Portal Inflammation: Change in Score | 52 weeks | Change from baseline in portal inflammation score. The amount of portal inflammation is based on central pathologist grading of liver biopsies: 0=none; 1=mild, 2=more than mild. Change in portal inflammation score has a possible range of -2 to +2, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement). |
| Secondary | Fibrosis: Patients With Improvement | 52 weeks | Improvement in fibrosis stage defined as any decrease in fibrosis stage comparing 52-week biopsy to baseline. |
| Secondary | Fibrosis: Change in Stage | 52 weeks | Change from baseline in fibrosis stage. The amount of fibrosis is based on central pathologist grading of liver biopsies: 0=none; 1a=mild, zone 3 perisinusoidal, 1b=moderate, zone 3, perisinusoidal, 1c=portal/periportal only, 2=zone 3 and periportal, any combination, 3=bridging, 4=cirrhosis. Fibrosis stages 1a, 1b, 1c recoded as 1, so the possible range of values for fibrosis stage was 0-4. Change in fibrosis stage has a possible range of -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement). |
| Secondary | Resolution of NASH | 52 weeks | Patients with a change from a histological diagnosis of definite NASH or indeterminate for NASH to not NASH at end of treatment |
| Secondary | Change in Serum Aminotransferase and Gamma-glutamyl Transpeptidase | 52 weeks | |
| Secondary | Change in Weight (kg) | 52 weeks | |
| Secondary | Change in Body-mass Index | 52 weeks | |
| Secondary | Change in Body-mass Index Z-score | 52 weeks | |
| Secondary | Change in Waist Circumference | 52 weeks | |
| Secondary | Change in Fasting Serum Glucose | 52 weeks | |
| Secondary | Change in Fasting Insulin | 52 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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