Vitamin E in patients with Non-alcoholic steatohepatitis (NASH) related compensated cirrhosis: An open label, randomized control trial
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients with NASH-related compensated cirrhosis belonging to CTP class A
1.Patients who decline to give consent.
2.Patients who are non-cirrhotic or have advanced fibrosis only.
3.Patients with current or past history of decompensation(s) (clinical jaundice, ascites, hepatic encephalopathy, and portal hypertension related bleeding).
4.Patients belonging to CTP class B or C.
5.Patients presenting with acute-on-chronic liver failure (ACLF)[30].
6.Patients with present or past clinical or imaging evidence of hepatocellular carcinoma/other malignancy(s).
7.Patients with present or past available data suggestive of any other competing or confounding etiologies for underlying cirrhosis.
8.Patients with severe cardio-pulmonary disease defined as NYHA class more than II, EF <40-45%, FEV1/FVC <60%.
9.Patient with severe renal insufficiency (eGFR < 30 ml/min/1.73 m2) or those requiring maintenance hemodialysis.
10.Patients on metformin, pioglitazone, liraglutide, saroglitazar or any other experimental/off-label treatment for NAFLD/NASH.
11.Patients who are pregnant or planning conception or are lactating.
12.Patients in whom FibroScan�® evaluation fails.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development new onset hepatic decompensations in patients with NASH-related compensated cirrhosis <br/ ><br> <br/ ><br>Timepoint: Follow up every 3months for 2 years post enrollment
- Secondary Outcome Measures
Name Time Method Development of HCCTimepoint: 2-years;Transplant-free survivalTimepoint: 2 years