| Trial ID: | L0375 |
| Source ID: | JPRN-jRCT2031210380
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| Associated Drug: |
Guanabenz
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| Title: |
Phase II physician-initiated clinical trial investigating the efficacy and safety of guanabenz acetate for non-alcoholic fatty liver disease associated with hypertension (G-Flash study)
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| Acronym: |
--
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| Status: |
Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
|
| Conditions: |
Non-alcoholic fatty liver disease/non-alcoholic steatohepatitis(NAFLD/NASH) <br>NAFLD,NASH,NAFLD/NASH
|
| Interventions: |
During the treatment period, the investigational drug is orally administered to groups A and B twice daily for 16 weeks. The number of administered tablets in each group is as follows: <br>A group: WY-8678, 4 mg/day: one tablet per session, twice a day<b
|
| Outcome Measures: |
Percentage of those where the liver fat content (%) measured by MRI-PDFF at 16 weeks decreased by 3.46% or more from baseline (%)1) Amount of change and rate of change from baseline in the measured values at 16 weeks were determined. The rate of change is defined as (value at 16 weeks - baseline value) / (baseline value). The following items were measured:<br>Percentage of subjects where the liver fat content (%) measured by MRI-PDFF at 16 weeks decreased by >= 3.46% from baseline for the 4 mg and 8 mg groups<br>Amount of change and rate of change in liver fat content measured by MRI-PDFF<br>Rate of change in ALT, AST, and gamma-GTP<br>Rate of change in weight<br>Rate of change in blood lipids (chylomicron cholesterol, chylomicron triglyceride, lipoprotein cholesterol, LDL triglyceride, VLDL cholesterol, VLDL triglyceride, free cholesterol, apoprotein A1, apoprotein B, adipsin, free fatty acid)<br>Rate of change in insulin resistance (HOMA-IR)<br>Rate of change in liver hardness (MRE)<br>Rate of change of fibrosis markers (ELF score, Fibrosis-4 [FIB-4])<br>2)Search for new markers related to liver disease and obesity metabolic disease<br>3)Occurrence rate of adverse events
|
| Sponsor/Collaborators: |
Kessoku Takaomi
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| Gender: |
All
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| Age: |
>= 20age old<= 75age old
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| Phases: |
Phase 2
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| Enrollment: |
28
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| Study Type: |
Interventional
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| Study Designs: |
randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
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| Start Date: |
20/10/2021
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
7 February 2022
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| Locations: |
Japan
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| URL: |
https://jrct.niph.go.jp/latest-detail/jRCT2031210380
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