An Investigator Initiated Prospective, Four Arms Randomized Comparative Study of Efficacy and Safety of Saroglitazar, Vitamin E and Life Style Modification in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)/ Non-alcoholic Steatohepatitis (NASH)

Last updated: January 24, 2021
Sponsor: Asian Institute of Gastroenterology, India
Overall Status: Active - Recruiting

Phase

3

Condition

Liver Disease

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT04193982
ECR/346/Inst/AP/2013/RR-16
  • Ages 18-60
  • All Genders

Study Summary

Saroglitazar and Vitamin E are both being extensively used in India for non alcoholic fatty liver disease, though none of these drugs are FDA approved for this indication.However they are backed up by number of studies which shows improvement in liver function , reduction in NAS score. However, there is no head to head trial , nor is there any study with a paired biopsy comparing two arms for a head to head study. We therefore designed this study to see the effect of Vitamin E vs Vitamin E plus saroglitazar vs Saroglitazar alone when compared to standard dietary and weight loss treatment for NAFLD with raised ALT levels.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Adults (age 18 to 60) 2. Confirmed Diagnosis of NAFLD established either by imaging (ultrasound, CT scan or MRI) or liver biopsy showing simple steatosis, within 6 monthsof the Screening Phase for this study. The diagnosis of NAFLD is made according to theAmerican Association for the Study of Liver Diseases (AASLD) criteria (Chalasanietal.2017).
  1. There is hepatic steatosis by imaging or histology,
  2. There is no significant alcohol consumption,
  3. There are no competing etiologies for hepatic steatosis
  4. There are no co-existing causes for chronic liver disease. 3. Patient'sdemonstration of understanding of study requirements and treatment procedures,willingness to comply with all protocol-required evaluations.
  5. Either take biopsy proven NAFLD or imaging based NAFLD with ALT more than 1.5times the upper limit of normal. (being considered as 32) 5. Liver biopsy wouldbe done in selected cases where the cause of transaminitis was uncertain ofpossible biopsy would be done on case to case basis.

Exclusion

Exclusion Criteria:

  1. Absence of regular or excessive use of alcohol within 2 years prior toinitial screening. History of alcohol will be taken from the patient and oneor more family member and patient will be defined as non-alcoholic if he/sheis a total abstainer or takes >20g (males) or 10g (females) of alcohol perday or greater than 14 drinks per week in males or greater than 7 drinks perweek in females. Approximately 10 g of alcohol equals one 'drink' unit. Oneunit equals 30 ml of distilled spirits, 355 ml beer, or 120 ml glass ofwine.
  2. Presence of alternative causes of fatty liver, including:
  • Weight loss >10% in the 6 months before the Screening Visit
  • Total parenteral nutrition, starvation or protein-calorie malnutrition
  • Use of drugs associated with NAFLD for more than 12 consecutive weeksin the 1 year before start of the study, including amiodarone,tamoxifen, methotrexate, systemic glucocorticoids, anabolic steroids,tetracycline, estrogens in doses higher than used in oralcontraceptives, vitamin A, L asparaginase, valproate, chloroquine, orantiretroviral drugs.
  1. History of bowel surgery, gastrointestinal (bariatric) surgery or undergoingevaluation for bariatric surgery for obesity, extensive small-bowelresection, or orthotopic liver transplants (OLT) or listed for OLT.
  2. History of other chronic liver disease (Viral hepatitis B or C, autoimmunehepatitis, cholestatic and metabolic liver diseases) and hemochromatosis.
  3. Patient has known cirrhosis (compensated /decompensated) either based onclinical criteria or liver histology or Imaging techniques.
  4. Patients with Hypothyroidism.
  5. Unstable cardiovascular disease, including:
  • unstable angina, (i.e., new or worsening symptoms of coronary heartdisease within the past 3 months), acute coronary syndrome within thepast 6 months, acute myocardial infarction in the past 3 months orheart failure of New York Heart Association class (III - IV) orworsening congestive heart failure, or coronary artery intervention,within the past 6 months
  • history of (within prior 3 months) or current unstable cardiacdysarrhythmias
  • uncontrolled hypertension (systolic BP>180 mmHg and/or diastolic BP >110 mmHg on two consecutive occasions)
  • stroke or transient ischemic attack within the prior 6 months
  1. History of myopathies or evidence of active muscle disease.
  2. History of malignancy in the past 5 years and/or active neoplasm with theexception of resolved superficial non-melanoma skin cancer.
  3. Participation in any other therapeutic clinical study in the past 3 months,including participation in any other NAFLD clinical trials.
  4. History of bladder disease and/or hematuria or has current hematuria exceptdue to a urinary tract infection.
  5. Illicit substance abuse within the past 12 months.
  6. Pregnant/lactating female (including positive pregnancy test at theScreening Visit)
  7. History or other evidence of severe illness or any other conditions thatwould make the patient, in the opinion of the investigator, unsuitable forthe study (such as poorly controlled psychiatric disease, HIV, coronaryartery disease or active gastrointestinal conditions that might interferewith drug absorption).
  8. Patients who will not comply with diet and lifestyle changes can be excludedfrom the final analysis.

Study Design

Total Participants: 250
Study Start date:
January 31, 2021
Estimated Completion Date:
October 31, 2021

Connect with a study center

  • Asian Institute of Gastroenterology Hospitals

    Hyderabad, Telangana 500089
    India

    Active - Recruiting

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