| Trial ID: | L0373 |
| Source ID: | NCT05147090
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| Associated Drug: |
Empagliflozin
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| Title: |
Effects of Empagliflozin on Preventing Fibrosis and Cirrhosis Progression in Nucleos(t)Ide Analogue-treated Chronic Hepatitis B Patients With Significant/Advanced Fibrosis or Cirrhosis: a Randomized, Double-blind Placebo-controlled Trial
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| Acronym: |
--
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| Status: |
Not recruiting
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| Study Results: |
No Results Available
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| Results: |
--
|
| Conditions: |
Chronic Hepatitis b;NAFLD;Cirrhosis;Fibrosis, Liver;Empagliflozin;SGLT2 Inhibitors
|
| Interventions: |
Drug: Empagliflozin 10 MG;Drug: Placebo pills
|
| Outcome Measures: |
Change in liver stiffness (measured by MRE)Remission of significant/advanced fibrosis and cirrhosis;Progression of significant/advanced fibrosis to cirrhosis (measured by MRE);Progression to decompensated cirrhosis;Change in liver stiffness (measured by transient elastography);Change in fat content (measured by transient elastography);Changes of alanine aminotransferase (ALT);Changes of aspartate aminotransferase (AST);Changes of alkaline phosphatase (ALP);Changes of gamma glutamyl transferase (GGT);Changes of fasting glucose;Changes of haemoglobin A1c (HbA1c);Changes of total cholesterol;Changes of low density lipoprotein (LDL);Changes of high density lipoprotein (HDL);Changes of body weight;Changes of body mass index (BMI);Changes of waist circumference;Changes of systolic blood pressure;Changes of diastolic blood pressure
|
| Sponsor/Collaborators: |
The University of Hong Kong
|
| Gender: |
All
|
| Age: |
18 Years80 Years
|
| Phases: |
Phase 4
|
| Enrollment: |
106
|
| Study Type: |
Interventional
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| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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| Start Date: |
22/11/2021
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
21 December 2021
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| Locations: |
--
|
| URL: |
https://clinicaltrials.gov/show/NCT05147090
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