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LAENNEC IV vs SC in Chronic Liver Disease
NCT06493799Phase 3
Key facts
- Status
- Recruiting
- Start
- Jul 2024
- Primary completion
- Mar 2026
- Countries
- 1
- Sponsor
- GC Wellbeing
- Modality
- Device-based Delivery
- Drugs
- LAENNEC
- Conditions
- Alcoholic Fatty Liver Disease (AFLD)non-alcoholic fatty liver disease (NAFLD)
01
Overview
Phase 3, randomised, open-label trial of LAENNEC in Alcoholic Fatty Liver Disease (AFLD) and non-alcoholic fatty liver disease (NAFLD), sponsored by GC Wellbeing. Primary endpoint: Change in ALT level relative to baseline at 6 weeks. Started Jul 2024; status: recruiting.
02
Design
- Study design
- RandomizedOpen-label
03
Endpoints
Primary
Change in ALT level relative to baseline
Secondary
Change in ALT level relative to baseline
Change in AST level relative to baseline
Change in Total Bilirubin level relative to baseline
Change in r-GT level relative to baseline
The rate of ALT normalization
The rate of AST normalization
ALT normalization time
The Rate of participants with ≤ 20% decrease of ALT relative to baseline
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