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Safety and Tolerability of Yaq-001 in Patients With Non-Alcoholic Steatohepatitis
Gut-derived endotoxaemia, microbial imbalance and bacterial translocation play an increasingly recognized role in the progression from non-alcoholic fatty liver disease (NAFLD) to its more advanced state, NASH (non-alcoholic steatohepatitis). Animal model studies confirmed that Yaq-001 reduces liver injury and prevents steatosis in these models which leads to the theoretical potential of Yaq-001 altering the microbiome and gut permeability in patients with NASH. The purpose of this clinical trial is to study the safety and tolerability of Yaq-001 in patients with NASH. Results from this study will lead to the design of future pivotal performance and safety trials for registration purposes. Candidate patients must be between 18-70 years old and have a clinical diagnosis of NASH, determined histologically or phenotypically, as well as meeting other clinical inclusion/exclusion criteria. Eligible patients will be randomly assigned to receive standard of care treatment plus Yaq-001, or standard of care treatment plus placebo). The treatment lasts for 48 weeks. During treatment, the patient will have 6 study visits. At all the visits, the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital. On two occasions the patient will have a liver Multiscan and on three occasions the patient will have a liver Fibroscan. 70 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.
Details
| Lead sponsor | Yaqrit Ltd |
|---|---|
| Phase | NA |
| Status | WITHDRAWN |
| Start date | Sun Jan 31 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sun Jan 31 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Non-Alcoholic Steatohepatitis
Interventions
- Yaq-001
- Placebo
Countries
France, Italy, United Kingdom, Switzerland, Portugal, Spain