Trial · NCT04618744
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment-Emergent Adverse Events | Screening through Week 16 | The Number of Treatment-Emergent Adverse Events (TEAE) according to CTCAE version 4.03. A TEAE is an adverse event for which the start date is on or after the date that the treatment began. |
| Secondary | Median MRPDFF at Baseline and Week 12 of Whole Liver | Baseline and Week 12 (Visit 8) | Median MRPDFF at Baseline and Week 12 of Whole Liver. Delineation by a central radiologist of the whole liver in the slice with the largest liver cross-section. The Liver was subdivided into 8 sections according to the Coinaud liver segmentation for MRI. |
| Secondary | Percent Change From Baseline of Median MRPDFF of Whole Liver | Baseline and Week 12 (Visit 8) | The percent change in MR PDFF from baseline to Week 12 of Whole Liver |
| Secondary | Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver | Baseline and Week 12 | Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver at Baseline and Week12. The Whole liver was delineated by a central radiologist. The liver was subdivided into 8 sections according to the Coinaud liver segmentation for MRI. |
| Secondary | Percent Change From Baseline in Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver | Screening and Week 12 (Visit 8) | The percent change from basline in liver fat content as measured by the mean MRI Proton density Fat Fraction (MR PDFF) at baseline and at week 12 of Whole Liver |
| Secondary | Median Magnetic Resonance Proton Density Fat Fraction (MR PDFF) of Liver Segment 3 | Baseline and Week 12 (Visit 8) | Median MRPDFF (percentage fat in the liver) of liver segment 3 as measured by MRI Proton Density Fat Fraction at baseline and at week 12. Delineation by a central radiologist of the Liver Segment 3 in the slice with the largest Liver Segment 3 cross-section. |
| Secondary | Percent Change From Baseline of Median MRPDFF of Liver Segment 3 | Baseline and Week 12 (Visit 8) | Percent Change from Baseline Median MRPDFF of Liver Segment measured at baseline and Week 12 (Visit 8) |
| Secondary | Mean MRPDFF of Liver Segment 3 | Baseline and Week 12 (Visit 8) | Mean MRPDFF of Liver Segment measured at baseline and Week 12 |
| Secondary | Percent Change of Mean MRPDFF of Liver Segment 3 | Baseline and Week 12 (Visit 8) | Percent change from baseline of mean MR PDFF measurement of liver segment 3 at baseline and week 12 |
| Secondary | Median MR PDFF of Liver Segment 6 | Screening and Week 12 (Visit 8) | Median Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8). Delineation by a central radiologist of Liver Segment 6 in the slice with the largest Liver Segment 6 cross-section. |
| Secondary | Percent Change From Baseline of Median MR PDFF of Liver Segment 6 | Screening and Week 12 (Visit 8) | Percent Change from Baseline of Median Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 |
| Secondary | Mean MR PDFF of Liver Segment 6 | Screening and Week 12 (Visit 8) | Mean Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8) |
| Secondary | Percent Change From Baseline of Mean MR PDFF of Liver Segment 6 | Screening and Week 12 (Visit 8) | Percent Change from Baseline Mean Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8) |
| Secondary | Median MRPDFF of Liver Segment 8 | Baseline and Week 12 (Visit 8) | Median MRPDFF of Liver Segment 8 measured at baseline and Week 12 (Visit 8) |
| Secondary | Percent Change in Median MRPDFF of Liver Segment 8 | Baseline and Week 12 (Visit 8) | Percent change from baseline in median MRPDFF of Liver segment 8 measured at baseline and week 12 (Visit 8). |
| Secondary | Mean MRPDFF of Liver Segment 8 | Baseline and Week 12 (Visit 8) | Liver fat percentage of liver segment 8 as measured by MRI Proton Density Fat Fraction (MR PDFF) at baseline and at week 12 (Visit 8). Delineation by a central radiologist of Liver Segment 8 in the slice with the largest Liver Segment 8 cross-section. |
| Secondary | Percent Change From Baseline in Mean MRPDFF of Liver Segment 8 | Baseline and Week 12 (Visit 8) | Percent change from baseline in MRPDFF of liver segment 8 at baseline and at week 12 (Visit 8) |
| Secondary | Liver Steatosis | Baseline and Week 12 (Visit 8) | Liver steatosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of decibels per meter (dB/M) |
| Secondary | Change in Liver Steatosis From Baseline | Baseline and Week 12 (Visit 8) | Change in Liver steatosis from baseline measured by FibroScan® at baseline and at week 12 (Visit 8), in units of decibels per meter (dB/M) |
| Secondary | Liver Fibrosis | Baseline and Week 12 (Visit 8) | Liver fibrosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of kilo Pascals (kPa). |
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.
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GET https://conductscience.org/api/trials/v1/NCT04618744/registered