Non-alcoholic steatohepatitis (NASH) MedDRA version: 12.1 Level: LLT Classification code 10053219 Term: non-alcoholic steatohepatitis
Conditions
Interventions
Trade Name: Normix
Product Name: Rifaximin
Product Code: 025300029
Pharmaceutical Form: Tablet
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject has provided written informed consent prior to screening • Men and women aged 18-70 years • Biopsy-proven NASH with no or mild to moderate fibrosis in the preceding year • Persistently abnormal ALT on 2 occasions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • NAFLD with cirrhosis (fibrosis score 4) • Other causes of chronic liver disease o Viral hepatitis (HBV, HCV negative) o Alcohol intake >14units/week (women) or >21units/week (men) o Haemachromatosis (abnormal transferrin saturation, haemochromatosis genotyping) • Evidence of hepatic decompensation o Ascites o Hepatic encephalopathy o Abnormal total bilirubin (except patients with Gilbert’s syndrome), albumin, prolonged prothrombin time, low platelets) o Oesophageal or gastric varices • Moderate or severe renal dysfunction (CKD3+, estimated GFR <60ml/min/1.73m2) • Hepatocellular carcinoma • Primary metabolic causes of hepatic steatosis (e.g. familial hypertriglyceridaemia, abetalipoproteinaemia) • Other malignancy • Pregnant or lactating women or women of childbearing potential unwilling/unable to use adequate contraceptive methods • Systemic inflammatory conditions o Arthritis o Connective tissue disorders o Inflammatory bowel disease • Myocardial infarction within 6 months • Stroke within 6 months • Bariatric surgery/ blind loop/ short bowel • Treatment known/suspected to change gut flora (e.g. systemic antibiotics, colestyramine, lactulose, polyethylene glycol) within 3 months • Treatment with drugs known to cause hepatic steatosis (e.g. corticosteroids, HAART, amiodarone, high dose oestrogens, tamoxifen) within 3 months • Initiation or major dose change of metformin, thiazolinediones, biguanides, statins, fibrates, anti-obesity medications or insulin within 3 months of enrolment • Patients with allergy to Rifaximin or Rifamycin • Patients with a cardiac pacemaker, history of penetrating eye injury, metal foreign body or any other contra-indication to MRI scanning, as specified in the local MRI safety checklist • Any other clinical, social or psychological issues which, in the opinion of the investigators may preclude satisfactory completion of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the antibiotic, Rifaximin, reduces liver inflammation in non-alcoholic steatohepatitis (NASH).;Secondary Objective: To determine whether Rifaximin's effect on bowel flora leads to: 1. Reduction in liver fat 2. Change in resistance to the energy storage hormone, insulin 3. Change in mediators of inflammation (cytokines) To determine how changes in the gut bacteria related to the measures stated above.;Primary end point(s): The change in serum alanine aminotransferase level after treatment with Rifaximin. | — |
Countries
United Kingdom
Outcome results
None listed